NCT01679717

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

August 23, 2012

Last Update Submit

May 4, 2015

Conditions

Thumb Osteoarthritis

Keywords

OsteoarthritisCMC1-jointPostoperative therapyInterposition arthroplasty of the thumbOccupational therapy

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in The Canadian Occupational Performance Measure (COPM) at 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.

    Baseline, 3, 6 and 12 months

  • Change from baseline in Patient satisfaction with the rehabilitation regimen at 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).

    Baseline, 3, 6 and 12 months

Secondary Outcomes (4)

  • 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

Other Outcomes (1)

  • Training diary

    Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.

Study Arms (2)

Early mobilisation after CMC1-surgery

ACTIVE COMPARATOR

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

Other: Early mobilisation after CMC1-surgery

Conservative treatment after CMC1-surgery

OTHER

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

Other: Early mobilisation after CMC1-surgery

Interventions

Early mobilisation after CMC1-surgeryOTHER

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

Conservative treatment after CMC1-surgeryEarly mobilisation after CMC1-surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet hospital

Oslo, N-0370, Norway

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ingvild Kjeken, Ph.d

    Department of Rheumatology, Diakonhjemmet hospital

    STUDY CHAIR

Central Study Contacts

Tove Nilsen, MSc

CONTACT

+47 22451500tove.nilsen@diakonsyk.no

Ingvild Kjeken, PhD

CONTACT

+47 22451500ingvild.kjeken@diakonsyk.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational therapist MSc

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 6, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

NO(1)