- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01679717
Postoperative Therapy After Interposition Arthroplasty in CMC1
May 4, 2015 updated by: Tove Nilsen, Diakonhjemmet Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tove Nilsen, MSc
- Phone Number: +47 22451500
- Email: tove.nilsen@diakonsyk.no
Study Contact Backup
- Name: Ingvild Kjeken, PhD
- Phone Number: +47 22451500
- Email: ingvild.kjeken@diakonsyk.no
Study Locations
-
-
-
Oslo, Norway, N-0370
- Recruiting
- Diakonhjemmet Hospital
-
Contact:
- Tove Nilsen, MSc
- Phone Number: +47 22451500
- Email: tove.nilsen@diakonsyk.no
-
Contact:
- Ingvild Kjeken, PhD
- Phone Number: +47 22451500
- Email: ingvild.kjeken@diakonsyk.no
-
Principal Investigator:
- Tove Nilsen, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early mobilisation after CMC1-surgery
Mobilisation at two weeks after operation.
The participants will wear a soft splint for six weeks.
|
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation.
Comparison of rigid and soft thumb splint.
|
Other: Conservative treatment after CMC1-surgery
Current standard procedure: Mobilisation at six weeks after operation.
The participants will wear a rigid splint for six weeks.
|
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation.
Comparison of rigid and soft thumb splint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3, 6 and 12 months
|
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).
|
Baseline, 3, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure for activity performance (MAP-hand).
Time Frame: Baseline, 3, 6 and 12 months
|
MAP-hand is a questionnaire consisting of questions about 18 standardised activities.
The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do).
The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.
|
Baseline, 3, 6 and 12 months
|
Grip force and pinch grip
Time Frame: Baseline, 3, 6 and 12 months
|
The electronical instrument Grippit will be used to measure grip force and pinch grip.
In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds.
The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.
|
Baseline, 3, 6 and 12 months
|
Joint mobility
Time Frame: Baseline, 3, 6 and 12 months
|
|
Baseline, 3, 6 and 12 months
|
Pain
Time Frame: Baseline, 3, 6, and 12 months
|
Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.
|
Baseline, 3, 6, and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training diary
Time Frame: Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.
|
The patients will be asked to report which date they performed exercises, which exercises they performed and how much pain they experienced after performing the exercises.
They will also be encouraged to write down their own comments /reflections regarding the training.
|
Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ingvild Kjeken, Ph.d, Department of Rheumatology, Diakonhjemmet Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 23, 2012
First Submitted That Met QC Criteria
September 3, 2012
First Posted (Estimate)
September 6, 2012
Study Record Updates
Last Update Posted (Estimate)
May 5, 2015
Last Update Submitted That Met QC Criteria
May 4, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H4/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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