Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT02579694
Status:
TERMINATED
Last Update Posted:
2017-07-19
First Post:
2015-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-18', 'releaseDate': '2018-04-11'}, {'resetDate': '2018-11-14', 'releaseDate': '2018-10-18'}], 'estimatedResultsFirstSubmitDate': '2018-04-11'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Difficulties finding subjects meeting enrollment criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of reported VAS pain from preoperative to post-planned explantation', 'timeFrame': '12 months', 'description': 'Planned removal of provisional device recommended between six and 9 months; 12-month analysis will capture time to planned removal.'}, {'measure': 'Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device', 'timeFrame': '12 months'}, {'measure': 'The proportion of devices where removal is attributed to healing and not device failure', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation of device integrity', 'timeFrame': '12 months', 'description': 'Device integrity defined as no device breakage or separation'}, {'measure': 'Radiographic evaluation of radiolucency', 'timeFrame': '12 months'}, {'measure': 'Radiographic evaluation of osteolysis', 'timeFrame': '12 months'}, {'measure': 'Complication rates over time', 'timeFrame': '12 months'}, {'measure': 'Comparison of range of motion in degrees from preoperative values', 'timeFrame': '12 months', 'description': 'Flexion, Extension, Radial Deviation, Ulnar Deviation'}, {'measure': 'Comparison of grip strength in kg from preoperative values', 'timeFrame': '12 months'}, {'measure': 'Comparison of reported VAS pain from preoperative values', 'timeFrame': '12 months'}, {'measure': 'Subject satisfaction based on a five-point scale from preoperative', 'timeFrame': '12 months'}, {'measure': 'Comparison of scapholunate angle from preoperative through radiographic evaluation', 'timeFrame': '12 months'}, {'measure': 'Comparison of scapholunate joint space from preoperative through radiographic evaluation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Scapholunate Injury']}, 'referencesModule': {'references': [{'pmid': '15465234', 'type': 'BACKGROUND', 'citation': 'Zarkadas PC, Gropper PT, White NJ, Perey BH. A survey of the surgical management of acute and chronic scapholunate instability. J Hand Surg Am. 2004 Sep;29(5):848-57. doi: 10.1016/j.jhsa.2004.05.008.'}, {'pmid': '21732026', 'type': 'BACKGROUND', 'citation': 'Caloia M, Caloia H, Pereira E. Arthroscopic scapholunate joint reduction. Is an effective treatment for irreparable scapholunate ligament tears? Clin Orthop Relat Res. 2012 Apr;470(4):972-8. doi: 10.1007/s11999-011-1953-4.'}, {'pmid': '17210436', 'type': 'BACKGROUND', 'citation': 'Aviles AJ, Lee SK, Hausman MR. Arthroscopic reduction-association of the scapholunate. Arthroscopy. 2007 Jan;23(1):105.e1-5. doi: 10.1016/j.arthro.2006.07.013. Epub 2006 Oct 16.'}, {'pmid': '22913993', 'type': 'BACKGROUND', 'citation': 'Larson TB, Gaston RG, Chadderdon RC. The use of temporary screw augmentation for the treatment of scapholunate injuries. Tech Hand Up Extrem Surg. 2012 Sep;16(3):135-40. doi: 10.1097/BTH.0b013e318257595b.'}, {'pmid': '16609495', 'type': 'BACKGROUND', 'citation': 'Rosenwasser MP, Miyasajsa KC, Strauch RJ. The RASL procedure: reduction and association of the scaphoid and lunate using the Herbert screw. Tech Hand Up Extrem Surg. 1997 Dec;1(4):263-72. No abstract available.'}, {'pmid': '1891931', 'type': 'BACKGROUND', 'citation': 'Herbert TJ. Acute rotary dislocation of the scaphoid: a new technique of repair using Herbert screw fixation across the scapho-lunate joint. World J Surg. 1991 Jul-Aug;15(4):463-9. doi: 10.1007/BF01675642.'}, {'pmid': '19252680', 'type': 'BACKGROUND', 'citation': 'Opreanu RC, Baulch M, Katranji A. Reduction and maintenance of scapholunate dissociation using the TwinFix screw. Eplasty. 2009;9:e7. Epub 2009 Jan 29.'}, {'pmid': '21700650', 'type': 'BACKGROUND', 'citation': 'Cognet JM, Levadoux M, Martinache X. The use of screws in the treatment of scapholunate instability. J Hand Surg Eur Vol. 2011 Oct;36(8):690-3. doi: 10.1177/1753193411410154. Epub 2011 Jun 23.'}, {'pmid': '22022028', 'type': 'BACKGROUND', 'citation': 'Bhat AK, Kumar B, Acharya A. Radiographic imaging of the wrist. Indian J Plast Surg. 2011 May;44(2):186-96. doi: 10.4103/0970-0358.85339.'}, {'pmid': '16060116', 'type': 'BACKGROUND', 'citation': 'Loredo RA, Sorge DG, Garcia G. Radiographic evaluation of the wrist: a vanishing art. Semin Roentgenol. 2005 Jul;40(3):248-89. doi: 10.1053/j.ro.2005.01.014. No abstract available.'}, {'pmid': '9250766', 'type': 'BACKGROUND', 'citation': 'Garcia-Elias M. The treatment of wrist instability. J Bone Joint Surg Br. 1997 Jul;79(4):684-90. doi: 10.1302/0301-620x.79b4.14192. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective-prospective clinical evaluation is to determine whether the SLIC Screw System provides provisional fixation to allow biological healing of the scapholunate interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from selected sites with acute scapholunate injury fulfilling inclusion and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects willing and able to comprehend and sign Informed Consent\n* Subjects who have received the SLIC screw as part of the treatment for scapholunate ligament repair or scapholunate reduction\n* Subjects with acute scapholunate injury, classified with Garcia-Elias Stage 1-4, OR Geissler Stage 1-3\n* Subjects \\>18 years of age at the time of surgery\n\nExclusion Criteria:\n\n* Subject diagnosed with chronic scapholunate injury\n* Subjects who underwent previous scapholunate procedure on the study wrist before implantation of the SLIC Screw System\n* Subjects with active or latent infection at the time of surgery\n* Subjects with sepsis at the time of surgery\n* Subjects diagnosed with osteoporosis at the time of surgery\n* Subjects with insufficient quantity and/or quality of bone\n* Subjects with cartilage degeneration on the bones at the time of surgery\n* Subjects with absence of potential for soft tissue healing at time of surgery, as documented by the investigator.\n* Female Subjects known to be pregnant\n* Subjects who were unable to follow postoperative care instructions, specifically, activity levels\n* Subjects who are unable or unwilling to return for postoperative study visits'}, 'identificationModule': {'nctId': 'NCT02579694', 'briefTitle': 'Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acumed, LLC'}, 'officialTitle': 'Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury', 'orgStudyIdInfo': {'id': '14013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acumed Scapholunate Intercarpal Screw', 'type': 'DEVICE', 'otherNames': ['SLIC Screw'], 'description': 'Evaluation of provisional fixation to allow biologic healing of the scapholunate interval'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert S Unsell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acumed, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-11', 'type': 'RELEASE'}, {'date': '2018-10-18', 'type': 'RESET'}, {'date': '2018-10-18', 'type': 'RELEASE'}, {'date': '2018-11-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Acumed, LLC'}}}}