Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

Recruiting now · Not applicable

Conditions studied: Scaphoid Fracture, Scaphoid Nonunion

In brief

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.

Key facts

Study ID

NCT05574582

Run by

Herlev and Gentofte Hospital

People needed

88

Starts

2023-02-15

Expected to finish

2028-01-01

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Open fractures
• Associated trans-scaphoid perilunate dislocation.
• Associated fracture in the hand/upper extremity.
• Previous failed surgical treatment for scaphoid delayed/non-union.
• Stage 2 SNAC or above.
• Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.
• Patients with gross humpback deformity of HLR >0.75 and/or DCA <70⁰.
• 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.

Where it is running

• University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark — Hellerup, Denmark (enrolling)

Full record on ClinicalTrials.gov

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