Actively Recruiting
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
Led by Herlev and Gentofte Hospital · Updated on 2023-03-01
88
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-68 years
- Scaphoid fracture without healing 2-6 months after fracture with displacement over 1mm or fragmentation and failed non-operative treatment
- Scaphoid fracture without healing over 6 months after fracture regardless of displacement or fragmentation
- ASA physical status classification 1 to 3
You will not qualify if you...
- Open fractures
- Associated trans-scaphoid perilunate dislocation
- Associated fracture in the hand or upper extremity
- Previous failed surgical treatment for scaphoid delayed or non-union
- Stage 2 scaphoid non-union advanced collapse (SNAC) or worse
- Avascular necrosis of the proximal pole confirmed by MRI and lack of bleeding during surgery
- Gross humpback deformity with height length ratio over 0.75 or dorsal cortical angle under 70 degrees
- Inability to understand Danish instructions, complete rehabilitation, or answer questionnaires due to physical or cognitive impairments
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark
Hellerup, Denmark, 2900
Actively Recruiting
Research Team
M
Morten Kjaer, MD
CONTACT
C
Camilla Stokkebro, Secretary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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