Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-06 @ 1:16 PM
Study NCT ID:
NCT06554093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D005598', 'term': 'Fractures, Spontaneous'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '• Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.\n\nIntervention: Medical Device - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.\n\n• Control arm: Standard of care - free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the screw implantation by Gertzbein-Robbins scale', 'timeFrame': 'Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection', 'description': 'Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan'}], 'secondaryOutcomes': [{'measure': 'Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.', 'timeFrame': '24 hours after surgery', 'description': 'Mean and STD Values in milli-gray (mGy) and seconds collected from the c-Arm'}, {'measure': 'Evaluate time-per-screw for the experimental device arm (PKS) arm.', 'timeFrame': 'Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)', 'description': 'Operative time per screw'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fusion', 'screw positioning', 'screw insertion'], 'conditions': ['Scoliosis', 'Scoliosis; Adolescence', 'Scoliosis Kyphosis', 'Scoliosis Lumbar Region', 'Scoliosis Thoracic Region', 'Pathologic Fracture']}, 'descriptionModule': {'briefSummary': 'The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\\[s\\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm', 'detailedDescription': 'Trial design\n\n* Allocation: Randomized\n* Interventional Model: Parallel Assignment (double armed)\n* Interventional Model Description: Dual center, prospective, randomized cohort study.\n* Masking: None (Open Label)\n* Primary Purpose: Treatment\n* Enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out).\n\nStudy arms\n\n1. Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.\n\n Interventions: Medical Devise - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels.\n2. Control arm: free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.\n\nInterventions: Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality.\n\nPrimary endpoints:\n\nEvaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan, in each study arm and comparatively.\n\nNumber of misaligned screws as per the Gertzbein-Robbins classification scale (Gertzbein and Robbins, 1990) class E screws class D screws class C screws class B screws class A screws\n\nSecondary endpoints:\n\n1. Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.\n2. Evaluate time-per-screw for the experimental device arm (PKS) arm.\n3. Length of stay - (non-critical)\n4. Estimated blood loss (EBL) - (non-critical)\n5. Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* 16 and above years old\n* Patients who are about to undergo open, instrumented spinal surgery\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Men and women\n* 16 and above years old\n* Patients who are about to undergo open, instrumented spinal surgery\n* Signed informed consent form'}, 'identificationModule': {'nctId': 'NCT06554093', 'acronym': 'PKSforPSP', 'briefTitle': 'Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Deep Health Ltd.'}, 'officialTitle': 'A Prospective, Dual Canter, Double Armed, Open Label, Clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in Spine Surgery', 'orgStudyIdInfo': {'id': 'CL0003'}, 'secondaryIdInfos': [{'id': '341268', 'type': 'OTHER', 'domain': 'IRAS(Integrated research application system)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical Device- PathKeeper System (PKS)', 'description': 'One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.\n\nIntervention: Medical Device - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.', 'interventionNames': ['Device: Medical Device - PKS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2D Fluoroscopy', 'description': 'Control arm: Standard of care - free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy', 'interventionNames': ['Device: Medical Device - PKS']}], 'interventions': [{'name': 'Medical Device - PKS', 'type': 'DEVICE', 'otherNames': ['Device- Fluoroscopy'], 'description': 'The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.', 'armGroupLabels': ['2D Fluoroscopy', 'Medical Device- PathKeeper System (PKS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Almas Khan, MD', 'role': 'CONTACT', 'email': 'almas.khan@nhs.net', 'phone': '+44 113 392 8575'}, {'name': 'Almas Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leeds Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To be done'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deep Health Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}