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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 106

Inclusion Criteria

a. Population (base)
- All adult patients with unstable shaft fractures and fractures with a
symptomatic rotational or angular deformity of the proximal phalanx requiring
operative treatment.

b. Inclusion criteria
- Patients >=18 years
- Single proximal phalangeal shaft fracture
- Unstable proximal phalangeal shaft (extra-articular) fracture requiring
operative treatment. Unstable is defined as:
o transverse of oblique fractures with rotational disorders
o scissoring fingers in flexion
o dislocation or re-dislocation (after closed reduction) in a cast:
* >2mm shortening
* >2mm translocation
* >25 degrees angulation
- All comminuted proximal phalangeal fractures
- All proximal phalangeal fractures (regardless exact dislocation measures)
resulting in swan neck-deformity, pseudo claw hand, shortening with extension
lag.
- Proximal phalangeal fractures with acceptable reduction at the ED,
re-dislocated within 1 week after the ED (evaluated by radiograph at the
out-patient clinic)

Exclusion Criteria

c. Exclusion criteria
- - Stable proximal phalangeal shaft (extra-articular) fracture requiring
conservative treatment. Stable is defined as:
o transverse of oblique fractures without rotational disorders
o no scissoring fingers in flexion
o no dislocation or re-dislocation (after closed reduction) in a cast:
* <2mm shortening,
* <2mm translocation
* <25 degrees angulation
- Proximal phalangeal fractures with acceptable reduction at the ED (evaluated
with a radiograph at the ED) without re-dislocation within 1 week (evaluated by
a radiograph within 1 week at the out-patient clinic) 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
<p>Function, pain and disability expressed as change during the first 3 months on<br /><br>the Michigan Hand Questionnaire Score (MHQ-DLV) measured at randomization and<br /><br>one, four weeks and 3 months post-operative The MHQ is a validated tool for<br /><br>assessing functional outcome in patients with complaints of the hand5,8. The<br /><br>MHQ is a questionnaire divided in six subscales; overall hand function,<br /><br>activities of daily living (ADLs), pain, work performance, aesthetics and<br /><br>patient satisfaction with hand function. Each subscale has a formula to<br /><br>calculate a score from 0 (severe disability) to 100 (no disability). The final<br /><br>score is a summation of the six individual item-scores divided by six and<br /><br>ranges from 0 (severe disability) to 100 (no disability). </p><br>

Secondary Outcome Measures