Assessment of bone healing by high resolution peripheral quantitative computed tomography (HR*pQCT) after corrective osteotomy of malunited distal radius fractures with or without bone grafting.

Withdrawn

Conditions: malunion
malunited distal radius fractures
10017322

Registration Number: NL-OMON47440

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 24

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

- The use of corticosteroids, bisphosphonates and/or other osteoporosis medication during surgical intervention or chronic use.
- Patients with local disorders (e.g. tumors, Paget*s disease, osteogenesis imperfecta)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcomes are:<br /><br><br /><br>1. Density bone parameters<br /><br>- Total region (mgHA/cm3)<br /><br>- Cortical density (mgHA/cm3)<br /><br>- Trabecular density (mgHA/cm3)<br /><br><br /><br>2. Structural parameters<br /><br>- Cortical Thickness (mm)<br /><br>- Trabecular Thickness (mm)<br /><br>- Trabecular Separation (mm)<br /><br>- Trabecular Number (mm*1)<br /><br><br /><br>3. Biomechanical properties<br /><br>- Stiffness in compression (kN/mm)<br /><br>- Stiffness in torsion and bending (kNmm/rad)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcomes are:<br /><br>- Objective functional outcomes: active range of motion, grip and pinch<br /><br>strength, Gartland and Werley score<br /><br>- Subjective functional outcomes: Disability of the Arm, Shoulder and Hand<br /><br>questionnaire (DASH), Patient-Rated Wrist Evaluation (PRWE) and EQ-5D-5L<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>- Total costs subdivided into inpatient hospital costs, inpatient physician<br /><br>services, outpatient facility costs and outpatient physician services<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 preoperative and postoperative, occupation<br /><br>and resumption of work.</p><br>