Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT06808594
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Retrospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-11', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic outcome', 'timeFrame': 'Through study completion, an average of 17 year', 'description': 'X-Rays showed that all the implants were correctly positioned, without any particular or evident erosion of the surrounding bone structures. A pattern of moderate or non-severe degree of arthrosis of the wrist could generally be found. By comparing the X-rays taken at the follow-up, it was possible to detect a general slight evolution of the arthritic in the wrist compared to what was visible at the beginning of the treatment, in all the patients.'}], 'secondaryOutcomes': [{'measure': 'DASH (Disabilities of the Arm, Shoulder, and Hand)', 'timeFrame': 'Through study completion, an average of 17 year', 'description': 'The DASH is a self-administered questionnaire of over 30 questions designed to measure function and symptoms in patients with any musculoskeletal disorder of the upper limb. MAX 100, MIN 0'}, {'measure': 'PRWE (Patient Rated Wrist Evaluation)', 'timeFrame': 'Through study completion, an average of 17 year', 'description': 'The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. MAX 50, MIN 0'}, {'measure': 'VAS (Visual Analogue Scale)', 'timeFrame': 'Through study completion, an average of 17 year', 'description': "The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. MAX 10, MIN 0"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'arthroplasty', 'Scaphoid fracture', 'Pyrocarbon', 'Bone implant'], 'conditions': ['Scaphoid Non-union Advanced Collapse (SNAC Wrist)']}, 'descriptionModule': {'briefSummary': "Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;\n* collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.\n\nExclusion Criteria:\n\n* patients for whom it was not possible to obtain informed consent to the processing of personal data.'}, 'identificationModule': {'nctId': 'NCT06808594', 'briefTitle': 'The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'The Use of APSI: Long Term Follow-up', 'orgStudyIdInfo': {'id': 'prog.74 CET prot.67418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long term follow-up of patients treated with APSI', 'description': 'Long-term clinical and radiographic outcomes in patients undergoing APSI (Adaptive Proximal Scaphoid Implant); evaluation of wrist strength and ROM (Range of Motion) on the operated side compared with the healthy side; evaluation of daily, work and sports autonomy with DASH (Disabilities of the Arm, Shoulder, and Hand) and PRWE (Patient Rated Wrist Evaluation) questionnaires and evaluating the return to normal daily, work and sports activities pre-surgery; quantification of pain at the site of surgery.', 'interventionNames': ['Device: APSI prosthesis implant']}], 'interventions': [{'name': 'APSI prosthesis implant', 'type': 'DEVICE', 'description': "The adaptative proximal scaphoid implant (APSI) is a pyrocarbon partial scaphoid prosthesis, ovoid and unfixed, which replaces the proximal pole of the scaphoid and allows adaptative mobility in the movements of the first chain and restores the geometry of the carpus, thus preventing the evolution in SNAC (Scaphoid Non-union Advanced Collapse). Pyrocarbon has good compatibility with joint cartilage and bone, a modulus of elasticity similar to bone minimizing stress shielding effects and resorption. The implant is designed with two radii of curvature: in the frontal plane, the smaller radius of curvature corresponds to the scaphoid fossa, and the larger radius of curvature is directed anteroposteriorly to the transverse plane. When it's correctly positioned, the smallest radius of the curvature is visible in the anteroposterior view, whereas it's greater in the lateral view. These two axes of the implant make it adaptable to the kinematics of the wrist.", 'armGroupLabels': ['Long term follow-up of patients treated with APSI']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Database of evaluated patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Hand Surgery Unit, Principal Investigator', 'investigatorFullName': 'Massimo Corain', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Integrata Verona'}}}}