Evaluating the utility of bone grafts in open wedge corrective osteotomy and plate fixation in patients with malunited distal radius fractures (WOPPeR trial)

Recruiting

Conditions: malunion
malunited distal radius fractures
10017322

Registration Number: NL-OMON56098

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 95

Inclusion Criteria

- Patients of either sex from the age of 18 years or above
- Symptomatic extra-articular malunion of the distal radius
- Eligible for open wedge osteotomy and plate fixation with or without bone
grafting
- Patients are able to undergo postoperative follow-up of at least 12 months

Exclusion Criteria

- Patients with known systemic or metabolic disorders leading to progressive
bone deterioration
- Chronic use of glucocorticoids
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcomes are:<br /><br>• Complications (number and severity) during and after the operation with a<br /><br>follow-up period of at least one year<br /><br>• Quality of life using the EQ-5D-5L questionnaire<br /><br>• Time to complete bone healing, defined as the time between the corrective<br /><br>osteotomy and bridging of the fracture site by bone or callus</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcomes are:<br /><br>• Subjective functional outcomes: Patient-Rated Wrist Evaluation (PRWE) and<br /><br>Disability of the Arm, Shoulder and Hand (DASH) questionnaire<br /><br>• Objective functional outcomes: active range of motion and grip strength<br /><br>• Cost effectiveness (including costs, medical consumption using iMCQ,<br /><br>productivity loss using iPCQ)<br /><br><br /><br>Age, gender, hand dominance, comorbidities, smoking, body mass index,<br /><br>indication for operation, hobbies, sporting activities, usage of all<br /><br>medications and vitamin supplements, occupation and resumption of work. </p><br>