Actively Recruiting

Phase Not Applicable
Age: 18Years - 68Years
All Genders
ID05574582

Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed/Non-union in Adults: Study Protocol for a Randomized Clinical Trial

Led by Herlev and Gentofte Hospital · Updated on 2023-03-01

88

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical methods for treating scaphoid delayed or non-union, a condition where a fractured wrist bone does not heal properly after several months. This trial focuses on adults aged 18 to 68 years who have scaphoid fractures that have not healed within 2 to 6 months with some displacement or over 6 months regardless of displacement, including those who have tried non-operative treatment. The study compares the time to bone union and functional outcomes between an arthroscopic-assisted graft reconstruction and an open graft reconstruction. The trial design is a randomized controlled study conducted at a single center, aiming to provide high-quality evidence to guide treatment decisions for this condition. Participants will be randomly assigned to one of two groups: one receiving arthroscopic assisted cancellous chips graft reconstruction, which is less invasive and may preserve wrist structures and blood supply, and the other undergoing a conventional open cancellous graft reconstruction using graft from the iliac crest with internal fixation by compression screw. Treatments are followed by repeated CT scans every two weeks from 6 to 16 weeks post-surgery to monitor bone healing. Patients are stratified by factors like smoking, fracture displacement, and involvement of the proximal pole. The study also includes long-term follow-up with online questionnaires up to 10 years after surgery. Participants will undergo clinical exams and imaging before surgery, with detailed assessments including CT scans to evaluate bone angulation and displacement, and MRI to assess blood supply when needed. Outcome measures include time to bone union, function and disability scores, pain levels, grip strength, and patient satisfaction. Follow-up visits occur at 1.5, 3, 6, 12, and 24 months post-surgery with additional online assessments at 5 and 10 years. Safety and complications are monitored throughout, and participants can withdraw at any time. This comprehensive monitoring aims to determine which surgical method offers better healing and function for patients with scaphoid delayed/non-union.

CONDITIONS

Brief Title

Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

Who Can Participate

Age: 18Years - 68Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18-68 years
  • Scaphoid fracture without healing 2-6 months after fracture with displacement >1mm or comminution and failed non-operative treatment
  • Scaphoid fracture without healing over 6 months after fracture regardless of displacement, comminution, or previous non-operative treatment
  • ASA physical status classification 1 to 3
Not Eligible

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/non-union
  • Stage 2 scaphoid non-union advanced collapse (SNAC) or higher
  • Avascular necrosis of the proximal pole confirmed by MRI and lack of punctate bleeding during surgery
  • Gross humpback deformity with height length ratio greater than 0.75 and/or dorsal cortical angle less than 70 degrees
  • Inability to understand Danish instructions, complete rehabilitation, or answer questionnaires due to physical or cognitive impairment as evaluated by surgeon at first visit

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) including clinical examination and CT scan of the wrist; MRI if proximal pole involved

Surgery

Duration - 1 day

Participants undergo either arthroscopic assisted C chips graft reconstruction or open cancellous graft reconstruction with internal fixation for scaphoid delayed/non-union.

1 surgical visit

Treatment

Duration - 6 to 16 weeks

Participants recover post-surgery while their bone healing is monitored regularly until union is established.

Repeated CT scans every 2 weeks during this period to assess bone healing; additional CT at 26 weeks if union is not achieved

Follow-up

Duration - Up to 120 months (10 years)

Participants have ongoing assessments of functional outcomes, pain, grip strength, and donor site morbidity to evaluate recovery and long-term effects.

Clinical and patient-reported outcome assessments at 1.5, 3, 6, 12, 24 months; questionnaires sent at 5 and 10 years

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

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Research Team

M

Morten Kjaer, MD

C

Camilla Stokkebro, Secretary

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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