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Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

RecruitingNAAges 18 Years - 68 YearsAllHerlev and Gentofte Hospital
NCT05574582 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed/nonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand/upper extremity, previous failed surgical treatment for scaphoid delayed/nonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity. Patients are stratified for smoking habits, proximal pole involvement, and displacement of \>/\<2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals f

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged 18-68 years. 2. A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \>1mm or comminution and failed non-operative treatment. 3. Scaphoid fracture without healing \>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried. 4. ASA 1-3. Exclusion Criteria: 1. Open fractures 2. Associated trans-scaphoid perilunate dislocation. 3. Associated fracture in the hand/upper extremity. 4. Previous failed surgical treatment for scaphoid delayed/non-union. 5. Stage 2 SNAC or above. 6. Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively. 7. Patients with gross humpback deformity of HLR \>0.75 and/or DCA \<70⁰. 8. Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.
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What it tests

  • Graft reconstruction and internal fixation with compression screw
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Where

1 site
University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark
Hellerup, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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