Assessment of bone healing by XtremeCT scanner after surgical correction of the wrist with or without bone from the hip crest.
- Conditions
- Malunited distal radius fracturesCorrective osteotomyBone healingHR-pQCT scannerMalunion van de distale radiusCorrectie-osteotomieBotgenezingXtremeCT scanner
- Registration Number
- NL-OMON25833
- Lead Sponsor
- Maastricht University Medical Centre (MUMC+)
- Brief Summary
1. Disseldorp DJG, Hannemann PFW, Poeze M, Brink PRG. Dorsal or volar plate fixation of the distal radius. Does the complication rate help us to choose? J Wrist Surg 2016;5:202–210.<br> 2. Disseldorp DJG, Hannemann PFW, Poeze M, Brink PRG. Is bone grafting necessary in the treatment of malunited distal radius fractures? J Wrist Surg. 2015 Augustus;4(3):207-13.<br> 3. de Jong JJ, Willems PC, Arts JJ, Bours SG, Brink PR, van Geel TA, Poeze M, Geusens PP, van Rietbergen B, van den Bergh JP. Assessment of the healing process in distal radius fractures by high resolution peripheral quantitative computed tomography. Bone. 2014 Jul;64:65-74.<br> 4. de Jong JJ, Heyer FL, Arts JJ, Poeze M, Keszei AP, Willems PC, van Rietbergen B, Geusens PP, van den Bergh JP. Fracture Repair in the Distal Radius in Postmenopausal Women: A Follow-Up 2 Years Postfracture Using HRpQCT. J Bone Miner Res. 2016 May;31(5):1114-22. <br> 5. Heyer FL, de Jong JJA, Smeets RJEM, Arts JJ, Poeze M, Geusens PP, van Rietbergen B, van den Bergh JP, Willems PC. A Case Report of Abnormal Fracture Healing as Detected With High-Resolution Peripheral Quantitative Computed Tomography. J Clin Densitom. 2017 Oct - Dec;20(4):486-489
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Patients of either sex from the age of 18 years or above.
- Symptomatic extra-articular malunion of the distal radius.
- 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 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) - 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)
- Secondary Outcome Measures
Name Time Method - Objective functional outcomes: active range of motion, grip and pinch strength<br /><br>- Subjective functional outcomes: Disability of the Arm, Shoulder and Hand questionnaire (DASH), Patient-Rated Wrist Evaluation (PRWE) and EQ-5D-5L <br /><br>- Complications (number and severity) during and after the operation with a follow-up period of at least one year <br /><br>- Total costs subdivided into inpatient hospital costs, inpatient physician services, outpatient facility costs and outpatient physician services