Comparing two methods for treating scaphoid bone healing issues
Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed/Non-union in Adults: Study Protocol for a Randomized Clinical Trial
NA · Herlev and Gentofte Hospital · NCT05574582
This study is testing two different surgical methods to see which one helps people with delayed or non-healing scaphoid fractures recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT05574582 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Danish citizens aged 18-68 with scaphoid delayed or non-union fractures.
Not a fit: Patients with open fractures, previous failed surgeries for scaphoid issues, or significant deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing rates and recovery times for patients with scaphoid fractures.
How similar studies have performed: Previous studies have shown varying success with different grafting techniques for scaphoid fractures, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hellerup
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scaphoid Fracture, Scaphoid Nonunion, Scaphoid, Scaphoid nonunion, Cancellous, Graft, Arthroscopic, Timo to union