Clinical Trial

Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

Recruiting
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Record status
This record was last updated March 1, 2023 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-07; most recent amendment 2023-02-28.
Status change: Not Yet Recruiting → Recruiting 2023-02-28
Trial Details
NCT Number NCT05574582
Lead Sponsor Herlev and Gentofte Hospital
Conditions Scaphoid Fracture, Scaphoid Nonunion
Enrollment 88 participants
Start Date 2023-02-15
Primary Completion 2026-01-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2023-03-01