Condition: Scaphoid Fracture · Scaphoid Nonunion · Sponsor: Herlev and Gentofte Hospital
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 from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.
This description comes directly from the study's public registry record.
Morten Kjaer, MD · +45 38672111 · morten.kjaer.02@regionh.dk
Camilla Stokkebro, Secretary · +45 38673280 · camilla.stokkebro@regionh.dk
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| University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark | Hellerup, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05574582