TY - JOUR

T1 - Arthroscopic versus open cancellous bone grafting for scaphoid delayed/nonunion in adults (SCOPE-OUT)

T2 - study protocol for a randomized clinical trial

AU - Kjær, Morten

AU - Rasmussen, Jeppe Vejlgaard

AU - Gvozdenovic, Robert

N1 - Publisher Copyright: © 2023, The Author(s).

PY - 2023/12

Y1 - 2023/12

N2 - Background: Scaphoid non-union results in pain and decreased hand function. Untreated, almost all cases develop degenerative changes. Despite advances in surgical techniques, the treatment is challenging and often results in a long period with a supportive bandage until the union is established. Open, corticocancellous (CC) or cancellous (C) graft reconstruction and internal fixation are often preferred. Arthroscopic assisted reconstruction with C chips and internal fixation provides minimal trauma to the ligament structures, joint capsule, and extrinsic vascularization with similar union rates. Correction of deformity after operative treatment is debated with some studies favouring CC, and others found no difference. No studies have compared time to union and functional outcomes in arthroscopic vs. open C graft reconstruction. We hypothesize that arthroscopic assisted C chips graft reconstruction of scaphoid delayed/non-union provides faster time to union, by at least a mean 3 weeks difference. Methods: 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 C graft reconstruction or arthroscopic assisted distal radius C chips graft reconstruction. Patients are stratified for smoking habits, proximal pole involvement and displacement of > / < 2 mm. 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. Discussion: The results of this study will contribute to the treatment algorithm of scaphoid delayed/non-union and assist hand surgeons and patients in making treatment decisions. Eventually, improving time to union will benefit patients in earlier return to normal daily activity and reduce society costs by shortening sick leave. Trial registration: ClinicalTrials.gov NCT05574582. Date first registered: September 30, 2022. Items from the WHO trial registry are found within the protocol.

AB - Background: Scaphoid non-union results in pain and decreased hand function. Untreated, almost all cases develop degenerative changes. Despite advances in surgical techniques, the treatment is challenging and often results in a long period with a supportive bandage until the union is established. Open, corticocancellous (CC) or cancellous (C) graft reconstruction and internal fixation are often preferred. Arthroscopic assisted reconstruction with C chips and internal fixation provides minimal trauma to the ligament structures, joint capsule, and extrinsic vascularization with similar union rates. Correction of deformity after operative treatment is debated with some studies favouring CC, and others found no difference. No studies have compared time to union and functional outcomes in arthroscopic vs. open C graft reconstruction. We hypothesize that arthroscopic assisted C chips graft reconstruction of scaphoid delayed/non-union provides faster time to union, by at least a mean 3 weeks difference. Methods: 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 C graft reconstruction or arthroscopic assisted distal radius C chips graft reconstruction. Patients are stratified for smoking habits, proximal pole involvement and displacement of > / < 2 mm. 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. Discussion: The results of this study will contribute to the treatment algorithm of scaphoid delayed/non-union and assist hand surgeons and patients in making treatment decisions. Eventually, improving time to union will benefit patients in earlier return to normal daily activity and reduce society costs by shortening sick leave. Trial registration: ClinicalTrials.gov NCT05574582. Date first registered: September 30, 2022. Items from the WHO trial registry are found within the protocol.

KW - Arthroscopic

KW - Cancellous

KW - Graft

KW - Randomized controlled trial

KW - Scaphoid

KW - Scaphoid nonunion

KW - Time to union

U2 - 10.1186/s13063-023-07281-5

DO - 10.1186/s13063-023-07281-5

M3 - Journal article

C2 - 37060040

AN - SCOPUS:85152582075

VL - 24

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 273

ER -