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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21352
Enrollment
106
Registered
2019-04-23
Start date
2019-09-01
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

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

Interventions

The intervention group will be treated with K-wire fixation in combination with direct post-operative mobilization, supervised by the hand physiotherapist. Surgery will be performed by a certified tra

Sponsors

-
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Contacts

Public ContactDorien Salentijn

OLVG/Maasstad ziekenhuis

d.a.salentijn@olvg.nl0633744440

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)