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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56098

Enrollment

Registered

2019-03-27

Start date

2019-05-31

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

malunion malunited distal radius fractures

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

Eligibility

Age

18 Years to 99 Years

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

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)