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Clinical Trials in Denmark / NCT05574582
Recruiting Not applicable

Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

NCT05574582 · tracked via the Priya Life Science Denmark tracker
Sponsor
Herlev and Gentofte Hospital
Phase
Not applicable
Started
2023-02-15
Last updated
2023-03-01

Condition(s) studied

Scaphoid FractureScaphoid Nonunion

Investigational drug(s) / intervention(s)

Graft reconstruction and internal fixation with compression screw

Graft reconstruction and internal fixation with compression screw: Patients suffering from scaphoid nonunion are treated surgically by debridement, graft reconstruction and internal fixation with compression screw

Study summary

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

Sex
ALL
Min age
18 Years
Max age
68 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time to Union — 6-16 weeks postoperative in 2 weeks intervals. If unions is not achieved a CT will be made 26 weeks postoperatively. If union is not achieved at that point, the patient will be presented for another treatment modality
    Assessed with CT-scans. Union is proclaimed if at least 50% bone bridging is recorded together with absence of pain in the clinical examination

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05574582 on ClinicalTrials.gov ↗ ← All trials in Denmark