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Supervised handtherapy versus self-management exercise regimen in conservative treatment of dislocations or hyperextension injury of the vinger

Dorsal dislocations or HyPerextension Injuries with a volar plate avulsion of the proximal iNterphalangeal joint, cOnservative treatment with or without supervised hand-Therapy?

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29119
Enrollment
222
Registered
2018-12-04
Start date
2019-12-02
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

volar plate injury, PIP dislocation, hyperextension injury of PIP volar plate injury, PIP dislocation, hyperextension injury of PIP

Interventions

De interventiegroep zal thuis oefenen aan de hand van duidelijk opgestelde oefeninstructies, startend binnen 7 dagen na trauma. Aanvullend zullen zij voor vier weken een strek-beperkende spalk krijgen

Sponsors

Leading the Change
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. Population (base) - All adult patients with a PIP hyperextension injury leading to a complete dorsal dislocation, objectified by a doctor at the emergency department or by radiograph at the emergency department. - All adult patients with PIP hyperextension injury leading to a volar plate avulsion, objectified by an avulsion fracture of the proximal volar part of the mid phalanx (< 40% of the joint) on a radiograph at the emergency department. b. Inclusion criteria - Patients 18 years and older - Single PIP hyperextension injuries or dislocation of the fingers - A stable joint after reduction, assessed by dorsal, volar, and lateral stress on the PIP joint in extension and 30 degrees of PIP flexion. - Standard conservative treatment with a dorsal block splint in 0 degrees extension for four weeks. - Avulsion fracture of the proximal volar part of the mid phalanx (< 40% of the joint)* on a radiograph at the emergency department. - Standardized Eaton classification: type I,II,IIIa

Exclusion criteria

Exclusion criteria: An avulsion fracture of the PIP joint, >40% of the articular surface - Re-displacement during digit motion - An unstable joint after reduction assessed by dorsal, volar, and lateral stress on the PIP joint, requiring operative treatment - Irreducible dislocations - Suspicion for interposition of the volar plate - Operation indication - Hyperextension injuries of the IP of the thumb - Multiple PIP hyperextension injuries or dislocation of the fingers - Patients with impaired hand function prior to injury due to arthrosis/neurological disorders of the upper limb - Multiple trauma patients (Injury Severity Score (ISS) ¡Ý16) - 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 - Patients 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) after three months.

Secondary

MeasureTime frame
Pain as indicated on a Visual Analogue Scale (VAS), Well-being with the Patient Specific Functional and pain Scales (PSFS), Understanding medical information with the Newest Vital Sign- Dutch language version (NVS-D), Total active range of motion of the hand (TAM), Patient satisfaction score, Patient expectation, quality of life, complications, work-absence and cost effectiveness and measurement of health status with the EQ-5D-5L.

Contacts

Public ContactDorien Salentijn

OLVG/ Maasstadziekenhuis

d.a.salentijn@olvg.nl0031 6 337 4444 0

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)