Postoperative Therapy After Interposition Arthroplasty in CMC1

NCT ID: NCT01679717

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

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In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.

Detailed Description

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Conditions

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Thumb Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early mobilisation after CMC1-surgery

Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.

Group Type ACTIVE_COMPARATOR

Early mobilisation after CMC1-surgery

Intervention Type OTHER

Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.

Conservative treatment after CMC1-surgery

Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.

Group Type OTHER

Early mobilisation after CMC1-surgery

Intervention Type OTHER

Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.

Interventions

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Early mobilisation after CMC1-surgery

Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
* Planned surgery(interposition arthroplasty) in CMC1
* Ability to communicate in Norwegian

Exclusion Criteria

* Surgery involving other joints of the hand in addition to CMC1.
* Previous surgery of the same thumb.
* Other diseases og injuries that could influence hand function.
* Mental or cognitive deficit.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Norwegian Women´s Public Health Association

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tove Nilsen

Occupational therapist MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingvild Kjeken, Ph.d

Role: STUDY_CHAIR

Department of Rheumatology, Diakonhjemmet hospital

Locations

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Diakonhjemmet hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Tove Nilsen, MSc

Role: CONTACT

+47 22451500

Ingvild Kjeken, PhD

Role: CONTACT

+47 22451500

Facility Contacts

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Tove Nilsen, MSc

Role: primary

+47 22451500

Ingvild Kjeken, PhD

Role: backup

+47 22451500

Other Identifiers

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H4/2012

Identifier Type: -

Identifier Source: org_study_id

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