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Outcome and cost-effectiveness of a dynamic Lucerne-cast versus immobilization by forearm-cast in patients with FraCtures (neck, sHaft, intra-Articular) of the MetacarPAl bone, requirinG Non-operative trEatment.

Outcome and cost-effectiveness of a dynamic Lucerne-cast versus immobilization by forearm-cast in patients with FraCtures (neck, sHaft, intra-Articular) of the MetacarPAl bone, requirinG Non-operative trEatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20452
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

Adult patients with metacarpal fractures (MCFs) 2-4 and 5th MCFs (other than neck fractures), requiring nonoperative treatment. The fracture needs to be diagnosed on a radiograph at the emergency department.

Interventions

INTERVENTION Functional treatment of wrist and fingers by a Lucerne cast. Functional treatment will lead to less stiffness. The principle of the Lucerne cast is securing the MCP joints in flexion but

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients =18 years - Single MCF 2-4 (neck, shaft or intra-articular)and 5th MCFs (other than neck fractures) - Conservative treatment with a dynamic or forearm cast for four weeks.

Exclusion criteria

Exclusion criteria: - Operation indication; functional restrictions due to shortening, rotation or angulation - Volar angulation of the 5th ray = 30 - Volar angulation of the 4th ray =30 - Volar angulation of the 3th and 2nd ray =20 - Rotation disorders; clinical functional restriction such as scissoring fingers - Metacarpal shortening by segmental bone loss or < 50% bone to bone contact - Irreducible dislocations - Operative treatment - Fifth metacarpal neck fractures - Multiple metacarpal fractures in one hand - Metacarpal fracture of the first ray - Operative treatment - Absence of one of the following radiographs: Posterior-Anterior, 3/4-shot. - 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 in Michigan Hand Questionnaire Score (MHQ) during the first three months. MHQ will be assessed at baseline/randomization, one week, three weeks, five weeks and twelve weeks after randomization. The MHQ is a validated tool for assessing functional outcome in patients with complaints of the hand6,9. The MHQ is a questionnaire divided in six subscales; overall hand function, activities of daily living (ADLs), pain, work performance, aesthetics and patient satisfaction with hand function. Each subscale has a formula to calculate a score from 0 (severe disability) to 100 (no disability). The final score is a summation of the six individual item-scores divided by six and ranges from 0 (severe disability) to 100 (no disability).

Secondary

MeasureTime frame
Secondary: 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)