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Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

NCT05574582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-03-01

No results posted yet for this 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.

Conditions

  • Scaphoid Fracture
  • Scaphoid Nonunion

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Principal Investigators

  • Robert Gvozdenoviz, MD · Orthopedic department, Copenhagen university hospital Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-01-01
Completion
2028-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574582 on ClinicalTrials.gov