K-wire fixation with direct moBilization versus Open Reposition anD intErnal fixation with direct mobilizAtion in Unstable proXimal phalangeal shaft fractures.

Conditions: All adult patients with unstable shaft fractures and fractures with a symptomatic rotational or angular deformity requiring operative treatment.

Registration Number: NL-OMON21352

Lead Sponsor: -

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 106

Inclusion Criteria

Patients =18 years
-Single proximal phalangeal shaft fracture
-Unstable shaft fractures and fractures with a symptomatic rotational or angular deformity requiring operative treatment.

Exclusion Criteria

- Stable proximal phalangeal shaft fracture requiring conservative treatment
- Proximal phalangeal shaft fracture of the thumb.
- Open fractures
- Multiple proximal phalangeal fractures
- Patients with impaired hand function prior to injury due to arthrosis/neurological disorders of the upper limb
- Multiple trauma patients (Injury Severity Score (ISS) =16)
- Other injuries in the ipsilateral extremity
- Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
- Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget’s disease, renal osteodystrophy, osteomalacia)
- Patients suffering from connective tissue disease or (joint) hyper-flexibility disorders such as Marfan’s, Ehler Danlos or other related disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Function, pain and disability expressed as change on the Michigan Hand Questionnaire Score (MHQ-DLV) over 3 months

Secondary Outcome Measures

Name	Time	Method
Pain, well-being, understanding medical information, total active motion of finger and wrist, patient satisfaction, patient expectation, quality of life, complications, work-absence, cost effectiveness.