Comparing two methods for treating scaphoid bone healing issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of two surgical techniques for treating scaphoid delayed and non-union fractures. Eighty-eight patients aged 18-68 will be randomly assigned to receive either an open iliac crest cancellous graft or an arthroscopic-assisted distal radius cancellous chip graft. The primary outcome measured will be the time to union, assessed through repeated CT scans over a 10-week period. The study aims to provide insights into which method may lead to better healing outcomes for patients with these specific fractures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18-68 years.
2. 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.
3. Scaphoid fracture without healing \>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.
4. ASA 1-3.

Exclusion Criteria:

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

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

Study contacts

• Principal investigator: Robert Gvozdenoviz, MD — Orthopedic department, Copenhagen university hospital Gentofte Hospital
• Study coordinator: Morten Kjaer, MD
• Email: morten.kjaer.02@regionh.dk
• Phone: +45 38672111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.