Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-04-12 @ 2:30 PM
Study NCT ID:
NCT05677061
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient and Assessor blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lag Screw migration measured as y-translation (mm)', 'timeFrame': '6 months PO', 'description': 'Lag screw migration measured as y-translation (mm) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Lag screw migration measured as translations in mm', 'timeFrame': '6 months PO', 'description': 'Lag screw migration measured as translations in mm along the three orthogonal axes (x and z) and rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed translations (total translation) and summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up'}, {'measure': 'Lag screw migration measured as rotations in degrees', 'timeFrame': '6 months PO', 'description': 'Lag screw migration measured as rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up'}, {'measure': 'Radiological measurements', 'timeFrame': '6 months', 'description': 'TAD AP+LAT, fracture reposition AP+LAT (mm)'}, {'measure': 'Clinical outcomes - HHS', 'timeFrame': '6 months PO', 'description': 'Change in Harris Hip Score (HHS) measured as a scale from 0 (worst) to 100 (best) from pre-operative til 6 months postoperative'}, {'measure': 'Clinical outcomes - NMS', 'timeFrame': 'Preoperative', 'description': 'New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative'}, {'measure': 'Clinical outcomes - Leg Lengths difference', 'timeFrame': '6 months', 'description': 'Leg Length difference in cm at 6 months follow-up indicate fracture impaction'}, {'measure': 'Clinical outcomes - TUG test', 'timeFrame': '6 months', 'description': 'Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stable Fractures (Evans I, II, IV)'], 'conditions': ['Intertrochanteric Fractures']}, 'referencesModule': {'references': [{'pmid': '37710269', 'type': 'DERIVED', 'citation': 'Krogh AC, Thillemann JK, Hansen TB, Holck K, Kristensen MT, Palm H, Stilling M. No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis. J Orthop Surg Res. 2023 Sep 14;18(1):686. doi: 10.1186/s13018-023-04170-0.'}]}, 'descriptionModule': {'briefSummary': 'Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures', 'detailedDescription': 'Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)\n* able to speak Danish\n* able to complete the postoperative controls\n* written consent\n\nExclusion Criteria:\n\n* unable to follow standard hip fracture regime\n* were breastfeeding\n* pregnant\n* terminal disease\n* in need of open fracture reduction\n* in need of DHS plate with an angle different from 135 degrees\n* insertion of fewer than 3 tantalum beads in the femoral head (for RSA)\n* TAD \\>20mm in two dimensions in the first postoperative x-ray\n* fracture displacement \\>20mm in two dimensions in the first postoperative x-ray'}, 'identificationModule': {'nctId': 'NCT05677061', 'briefTitle': 'Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures', 'orgStudyIdInfo': {'id': 'H-KF-298036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HA-coated', 'description': 'Hydroxyapatite coating on Screw thread of DHS', 'interventionNames': ['Device: Dynamic Hip Screw with HA-coating (Hiploc)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NON-coated', 'description': 'No coating on Screw thread of DHS', 'interventionNames': ['Device: Dynamic Hip Screw without coating (Hiploc)']}], 'interventions': [{'name': 'Dynamic Hip Screw with HA-coating (Hiploc)', 'type': 'DEVICE', 'description': 'During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture', 'armGroupLabels': ['HA-coated']}, {'name': 'Dynamic Hip Screw without coating (Hiploc)', 'type': 'DEVICE', 'description': 'During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture', 'armGroupLabels': ['NON-coated']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not possible due til GDPR restrictions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospitalsenheden Vest', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}