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Corrective osteotomy of the distal radius: evaluation of a patient-tailored positioning and fixation plate.

Corrective osteotomy of the distal radius: evaluation of a patient-tailored positioning and fixation plate. - Patient-tailored Corrective Osteotomy (PCO)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43538
Enrollment
48
Registered
2016-08-12
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

abnormal bone healing after wrist fracture distal radius fracture malunion

Interventions

One group (n=24) will undergo a corrective osteotomy procedure, in which standard anatomical plating will be used for bone fixation. The other group (n=24) will undergo corrective osteotomy using pa

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients are adults aged 18 years or over with a symptomatic malunion after distal radius fracture.

Exclusion criteria

Exclusion criteria: - Bony deformities in the contralateral distal forearm. - Congenital skeletal disorders (Madelung deformity). - Not able to understand the written informed consent. - Pregnancy.

Design outcomes

Primary

MeasureTime frame
Functional outcome of the wrist is assessed through physical examination, measuring: flexion, extension, pronation, supination, radial deviation and ulnar deviation.

Secondary

MeasureTime frame
Accuracy is calculated using computed tomography imaging, providing us with: dorsal collapse, radial collapse and rotational deformation. Total costs are assessed using direct medical costs, operation time, indirect costs (aftercare) and workplace absenteeism. Self-assessed quality-of-life is assessed using the EuroQol EQ-5D-5L questionnaire.irect medical costs, operation time, indirect costs (aftercare), workplace absenteeism, self-assessed quality-of-life (using EuroQol EQ-5D-5L questionnaire). Other study parameters: age, gender, body weight, smoking, alcohol, diabetes, NSAID usage.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)