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Clinical Trials/NCT01679717
NCT01679717
Unknown
Not Applicable

Postoperative Therapy After Interposition Arthroplasty in CMC1

Diakonhjemmet Hospital1 site in 1 country70 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thumb Osteoarthritis
Sponsor
Diakonhjemmet Hospital
Enrollment
70
Locations
1
Primary Endpoint
Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
December 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tove Nilsen

Occupational therapist MSc

Diakonhjemmet Hospital

Eligibility Criteria

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 CMC
  • Previous surgery of the same thumb.
  • Other diseases og injuries that could influence hand function.
  • Mental or cognitive deficit.

Outcomes

Primary Outcomes

Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.

Time Frame: Baseline, 3, 6 and 12 months

The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.

Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.

Time Frame: Baseline, 3, 6 and 12 months

Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).

Secondary Outcomes

  • Measure for activity performance (MAP-hand).(Baseline, 3, 6 and 12 months)
  • Grip force and pinch grip(Baseline, 3, 6 and 12 months)
  • Joint mobility(Baseline, 3, 6 and 12 months)
  • Pain(Baseline, 3, 6, and 12 months)

Study Sites (1)

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