Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-68
SponsorHerlev and Gentofte Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged 18-68 years.

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.

Scaphoid fracture without healing >6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.

ASA 1-3.

Disqualifiers

Open fractures

Associated trans-scaphoid perilunate dislocation.

Associated fracture in the hand/upper extremity.

Previous failed surgical treatment for scaphoid delayed/non-union.

Trial design

Treatments tested in this trial

  • Graft reconstruction and internal fixation with compression screw

Treatment groups

88 Participants
are divided into 2 treatment groups

Locations

1
University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark2900, Hellerup Denmark

Sponsors and collaborators

Herlev and Gentofte Hospital

Lead sponsor