Assessment of bone healing by XtremeCT scanner after surgical correction of the wrist with or without bone from the hip crest.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25833

Enrollment

Registered

2018-05-03

Start date

2018-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malunited distal radius fractures Corrective osteotomy Bone healing HR-pQCT scanner Malunion van de distale radius Correctie-osteotomie Botgenezing XtremeCT scanner

Interventions

All included patients will undergo an open wedge osteotomy and plate fixation according to the standard surgical techniques. In one group, the bone defect will be filled with bone graft of the iliac c

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
1. Density bone parameters: - Total region (mgHA/cm3) - Cortical density (mgHA/cm3) - Trabecular density (mgHA/cm3) 2. Structural parameters: - Cortical Thickness (mm) - Trabecular Thickness (mm) - Trabecular Separation (mm) - Trabecular Number (mm-1) 3. Biomechanical properties: - Stiffness in compression (kN/mm) - Stiffness in torsion and bending (kNmm/rad)	—

Secondary

Measure	Time frame
- Objective functional outcomes: active range of motion, grip and pinch strength - Subjective functional outcomes: Disability of the Arm, Shoulder and Hand questionnaire (DASH), Patient-Rated Wrist Evaluation (PRWE) and EQ-5D-5L - Complications (number and severity) during and after the operation with a follow-up period of at least one year - Total costs subdivided into inpatient hospital costs, inpatient physician services, outpatient facility costs and outpatient physician services	—

Measure

Time frame

- Objective functional outcomes: active range of motion, grip and pinch strength - Subjective functional outcomes: Disability of the Arm, Shoulder and Hand questionnaire (DASH), Patient-Rated Wrist Evaluation (PRWE) and EQ-5D-5L - Complications (number and severity) during and after the operation with a follow-up period of at least one year - Total costs subdivided into inpatient hospital costs, inpatient physician services, outpatient facility costs and outpatient physician services

—

Contacts

Public ContactD. Disseldorp

Medisch Universitair Ziekenhuis Maastricht Afdeling Algemene Heelkunde Postbus 5800

d.disseldorp@student.maastrichtuniversity.nl+31 (0)6 48646448

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)