Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-31 @ 9:02 AM
Study NCT ID:
NCT02749058
Status:
SUSPENDED
Last Update Posted:
2023-03-02
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hip disability and Osteoarthritis Outcome Score (HOOS)', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)'}, {'measure': 'Change in Hip disability and Osteoarthritis Outcome Score (HOOS)', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)'}], 'secondaryOutcomes': [{'measure': 'Change in Six minutes walk test distance', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)'}, {'measure': 'Change in Six minutes walk test distance', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)'}, {'measure': 'Change in 30 seconds chair stand test', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)'}, {'measure': 'Change in 30 seconds chair stand test', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)'}, {'measure': 'Hip Proprioception Evaluation Flexion - Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip flexion repositioning error (active and passive repositioning)'}, {'measure': 'Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip abduction repositioning error (active and passive repositioning)'}, {'measure': 'Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip external rotation repositioning error (active and passive repositioning)'}, {'measure': 'Hip Proprioception Evaluation Flexion- Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip flexion repositioning error (active and passive repositioning)'}, {'measure': 'Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip abduction repositioning error (active and passive repositioning)'}, {'measure': 'Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip external rotation repositioning error (active and passive repositioning)'}, {'measure': 'Active hip Range Of Motion Flexion- degree', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip flexion maximal active Range of Motion'}, {'measure': 'Active hip Range Of Motion Abduction- degree', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip abduction maximal active Range of Motion'}, {'measure': 'Active hip Range Of Motion External Rotation- degree', 'timeFrame': 'Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)', 'description': 'Measures of hip external rotation maximal active Range of Motion'}, {'measure': 'Active hip Range Of Motion Flexion- degree', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip flexion maximal active Range of Motion'}, {'measure': 'Active hip Range Of Motion Abduction- degree', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip abduction maximal active Range of Motion'}, {'measure': 'Active hip Range Of Motion External Rotation- degree', 'timeFrame': 'Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)', 'description': 'Measures of hip external rotation maximal active Range of Motion'}, {'measure': 'Surgical time- minutes', 'timeFrame': 'The day of the surgical procedure', 'description': 'This will be measured from the time of incision to the time the dressing is applied'}, {'measure': 'Percent hemoglobin drop', 'timeFrame': 'Up to 2 weeks after surgery (during inpatient stay)', 'description': 'Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['capsulectomy', 'capsulotomy'], 'conditions': ['Hip Arthrosis']}, 'referencesModule': {'references': [{'pmid': '11805930', 'type': 'BACKGROUND', 'citation': 'Hewitt JD, Glisson RR, Guilak F, Vail TP. The mechanical properties of the human hip capsule ligaments. J Arthroplasty. 2002 Jan;17(1):82-9. doi: 10.1054/arth.2002.27674.'}, {'pmid': '18237703', 'type': 'BACKGROUND', 'citation': 'Martin HD, Savage A, Braly BA, Palmer IJ, Beall DP, Kelly B. The function of the hip capsular ligaments: a quantitative report. Arthroscopy. 2008 Feb;24(2):188-95. doi: 10.1016/j.arthro.2007.08.024. Epub 2007 Nov 26.'}, {'pmid': '9479711', 'type': 'BACKGROUND', 'citation': 'Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.'}, {'pmid': '22087603', 'type': 'BACKGROUND', 'citation': 'Moraes MR, Cavalcante ML, Leite JA, Macedo JN, Sampaio ML, Jamacaru VF, Santana MG. The characteristics of the mechanoreceptors of the hip with arthrosis. J Orthop Surg Res. 2011 Nov 16;6:58. doi: 10.1186/1749-799X-6-58.'}, {'pmid': '22588756', 'type': 'BACKGROUND', 'citation': 'Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.'}, {'pmid': '12777182', 'type': 'BACKGROUND', 'citation': 'Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003 May 30;4:10. doi: 10.1186/1471-2474-4-10. Epub 2003 May 30.'}, {'pmid': '31680746', 'type': 'DERIVED', 'citation': 'Ometti M, Brambilla L, Gatti R, Tettamanti A, La Cava T, Pironti P, Fraschini G, Salini V. Capsulectomy vs capsulotomy in total hip arthroplasty. Clinical outcomes and proprioception evaluation: Study protocol for a randomized, controlled, double blinded trial. J Orthop. 2019 Sep 12;16(6):526-533. doi: 10.1016/j.jor.2019.09.020. eCollection 2019 Nov-Dec.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to evaluate the differences in functional activities and proprioception after surgery in subjects who underwent hip prosthesis implant with capsulotomy or capsulectomy.', 'detailedDescription': 'Concerning hip arthroplasty surgery, in patients affected by coxarthrosis, there are two different techniques: one is capsulectomy and the second one is capsulotomy with repairing the capsule at the end of the procedure. Both preserving and excising the capsule are accepted methods and the choice whether repairing the capsule or not is up to the surgeon, since studies have not yet demonstrated the superiority of one of the two techniques. Articular capsule has a physiological role in joint stability and proprioception. The presence of proprioceptive nerve endings in hip joint capsule has been observed both in healthy patients and in those affected by coxarthrosis.\n\nIf capsulectomy is performed during primary hip arthroplasty, the pseudocapsule that is formed in place of the native capsule will not have any active neurophysiological role in the hip.\n\nFor this reason, investigators compare the two surgical techniques with the purpose of highlighting, if existing, the superiority of one technique on the other in terms of better functional recovery and proprioceptive sensibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective unilateral primary hip prosthesis utilizing direct anterior approach\n* Age ≥ 18\n* Signature of the informed consent\n\nExclusion Criteria:\n\n* Documented peripheral neuropathies\n* Documented central nervous system diseases that may compromise the balance and/or proprioception\n* Presence of other joint prosthesis in the lower limbs\n* Revision hip arthroplasty\n* Symptomatic osteoarthritis of other joints in the lower limbs (including the controlateral hip) or the spine\n* BMI \\> 35\n* Systemic diseases or clinical conditions that could interfere with the clinical study\n* Neuromuscular diseases'}, 'identificationModule': {'nctId': 'NCT02749058', 'briefTitle': 'Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation', 'orgStudyIdInfo': {'id': 'CAP_Feb16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Capsulectomy', 'description': 'Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty', 'interventionNames': ['Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty']}, {'type': 'OTHER', 'label': 'Capsulotomy', 'description': 'Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty', 'interventionNames': ['Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty']}], 'interventions': [{'name': 'Capsulectomy in Direct Anterior Total Hip Arthroplasty', 'type': 'PROCEDURE', 'description': 'Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.', 'armGroupLabels': ['Capsulectomy']}, {'name': 'Capsulotomy in Direct Anterior Total Hip Arthroplasty', 'type': 'PROCEDURE', 'description': 'Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.', 'armGroupLabels': ['Capsulotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Marco Ometti, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gianfranco Fraschini', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}