Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-02-06 @ 2:44 AM
Study NCT ID:
NCT04258605
Status:
TERMINATED
Last Update Posted:
2025-04-03
First Post:
2020-02-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ASHCOM Shoulder System and Its Related Instruments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carina.hafner@zimmerbiomet.com', 'phone': '+41797073093', 'title': 'Carina Hafner', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limitations of this study are the low overall sample size of 24 cases as well as the short follow-up period of three years.'}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of surgery until study termination (up to 3 years)', 'eventGroups': [{'id': 'EG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Not study related death', 'notes': 'Patient died from Covid two months after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival of Implant System (Kaplan Meier)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.\n\nDue to early study termination, the survival of the implant was analyzed at 3 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.91', 'spread': '8.18', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.07', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.95', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '9.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'The small sample size of arm "ASHCOM Shoulder System subjects - Fracture humeral stem" of 2 cases is too low for a statistical analysis.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values account for preoperative versus postoperative mean values at 1 and 2 years'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative (baseline), 1 year, 2 years post-operative', 'description': 'The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years.\n\nThe Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.'}, {'type': 'SECONDARY', 'title': 'Oxford Shoulder Score (OSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.27', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': '3-6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.81', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.62', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.8', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'The small sample size of arm "ASHCOM Shoulder System subjects - Fracture humeral stem" of 2 cases is too low for a statistical analysis.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible.\n\nThe outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '3-6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'The small sample size of arm "ASHCOM Shoulder System subjects - Fracture humeral stem" of 2 cases is too low for a statistical analysis.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 3-6 months and 1 year follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Subjective Shoulder Value (SSV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'title': 'Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '14.14', 'groupId': 'OG001'}]}]}, {'title': '3-6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '62.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.74', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.74', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.19', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'The small sample size of arm "ASHCOM Shoulder System subjects - Fracture humeral stem" of 2 cases is too low for a statistical analysis.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.", 'unitOfMeasure': 'percentage of normal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit. For one patient the score was not collected at the 3-6 months follow-up visit and for two patients at the 1 year follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Radiographic Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'OG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'classes': [{'categories': [{'title': 'Any radiographic findings - Yes:', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Any radiographic findings - No:', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years post-operative', 'description': 'Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ASHCOM Shoulder System subjects - Uncemented humeral stem: The number analyzed at 2 years is 21, as one patient passed away prior to the 3-6 month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'FG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem.\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '22'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '22'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Early study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'implants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ASHCOM Shoulder System Subjects - Uncemented Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'BG001', 'title': 'ASHCOM Shoulder System Subjects - Fracture Humeral Stem', 'description': 'Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem\n\nASHCOM Shoulder System: Reverse Shoulder Arthroplasty'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.14', 'spread': '6.14', 'groupId': 'BG000'}, {'value': '72.5', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '70.33', 'spread': '5.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Preop BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.34', 'spread': '2.46', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '25.99', 'spread': '2.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-13', 'size': 180249, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-03T05:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Termination of PMCF study due to product discontinuation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2020-02-04', 'resultsFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-14', 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of Implant System (Kaplan Meier)', 'timeFrame': '3 years', 'description': 'The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.\n\nDue to early study termination, the survival of the implant was analyzed at 3 years.'}], 'secondaryOutcomes': [{'measure': 'The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)', 'timeFrame': 'Pre-operative (baseline), 1 year, 2 years post-operative', 'description': 'The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years.\n\nThe Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).'}, {'measure': 'Oxford Shoulder Score (OSS)', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible.\n\nThe outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19."}, {'measure': 'EQ-5D-5L Score', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst."}, {'measure': 'Subjective Shoulder Value (SSV)', 'timeFrame': 'Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative', 'description': "The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal."}, {'measure': 'Radiographic Parameters', 'timeFrame': '2 years post-operative', 'description': 'Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Injuries', 'Shoulder Pain', 'Arthropathy; Traumatic', 'Arthroplasty Complications']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.', 'detailedDescription': 'This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.\n\nThe primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.\n\nThe secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from severe shoulder pain and disability indicated for implantation of the ASHCOM Shoulder System and who meet all inclusion and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is capable of understanding the doctor\'s explanations, following his instructions and is able to participate in the follow-up program.\n* Patient has given written consent to take part in the study by signing the "Patient Consent Form".\n* Patient is 18-80 years of age, inclusive.\n* Patient is skeletally mature.\n* Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.\n* Patient\'s joint is anatomically and structurally suited to receive the selected implants.\n* Patient has a functional deltoid muscle.\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent or to comply with the follow-up program.\n* Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable subject.\n* Patient meets at least one of the contraindications:\n\n * Signs of infection\n * Significant injury to the upper brachial plexus\n * Non-functional deltoid muscle\n * Insufficient quality and/or quantity of glenoid or humeral bone\n * Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention'}, 'identificationModule': {'nctId': 'NCT04258605', 'briefTitle': 'ASHCOM Shoulder System and Its Related Instruments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'CME2017-67E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASHCOM Shoulder System subjects', 'description': 'Subjects implanted with the ASHCOM Shoulder System', 'interventionNames': ['Device: ASHCOM Shoulder System']}], 'interventions': [{'name': 'ASHCOM Shoulder System', 'type': 'DEVICE', 'description': 'Reverse Shoulder Arthroplasty', 'armGroupLabels': ['ASHCOM Shoulder System subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97100', 'city': 'Ragusa', 'country': 'Italy', 'facility': 'Clinica del Mediterraneo', 'geoPoint': {'lat': 36.92574, 'lon': 14.72443}}], 'overallOfficials': [{'name': 'Marcello Stamilla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica del Mediterraneo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}