Thumb OsteoarthritisNCT01679717
Postoperative Therapy After Interposition Arthroplasty in CMC1
A study testing Early mobilisation after CMC1-surgery in people with Thumb Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Early mobilisation after CMC1-surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
- Planned surgery(interposition arthroplasty) in CMC1
- Ability to communicate in Norwegian
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Diakonhjemmet hospital
Oslo, N-0370
Tove Nilsen, MSc, +47 22451500, tove.nilsen@diakonsyk.no
Ingvild Kjeken, PhD, +47 22451500, ingvild.kjeken@diakonsyk.no
About this study
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.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Early mobilisation after CMC1-surgery
- Keywords
- Osteoarthritis, CMC1-joint, Postoperative therapy, Interposition arthroplasty of the thumb, Occupational therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilisation after CMC1-surgeryOther
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilisation after CMC1-surgery | Active comparator | Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks. Receives: 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. Receives: Other: Early mobilisation after CMC1-surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (4)
Measure for activity performance (MAP-hand).
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.
Measured: Baseline, 3, 6 and 12 months
Grip force and pinch grip
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.
Measured: Baseline, 3, 6 and 12 months
Joint mobility
- The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters.
- Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer.
- The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.
Measured: Baseline, 3, 6 and 12 months
Pain
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.
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Responsible party
- Principal investigator, Tove Nilsen, Diakonhjemmet Hospital
- Investigators
- Ingvild Kjeken, Ph.d, Study chair, Department of Rheumatology, Diakonhjemmet hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679717
- Sponsor's protocol ID
- H4/2012
- Status last verified
- May 2015
- First submitted
- 23 Aug 2012
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Therapy After Interposition Arthroplasty in CMC1
- ClinicalTrials.gov ID
- NCT01679717
- Acronym / sponsor ID
- H4/2012
- Conditions
- Thumb Osteoarthritis
- Keywords
- Osteoarthritis, CMC1-joint, Postoperative therapy, Interposition arthroplasty of the thumb, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilisation after CMC1-surgery | Active comparator | Other: Early mobilisation after CMC1-surgeryMobilisation at two weeks after operation. The participants will wear a soft splint for six weeks. |
| Conservative treatment after CMC1-surgery | Other | Other: Early mobilisation after CMC1-surgeryCurrent standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
- Planned surgery(interposition arthroplasty) in CMC1
- Ability to communicate in Norwegian
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilisation after CMC1-surgeryComparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint. | Other | Conservative treatment after CMC1-surgery, Early mobilisation after CMC1-surgery |
Primary outcome
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).
4 secondary outcomes
Measure for activity performance (MAP-hand).
Time frame: Baseline, 3, 6 and 12 months
Grip force and pinch grip
Time frame: Baseline, 3, 6 and 12 months
Joint mobility
Time frame: Baseline, 3, 6 and 12 months
Pain
Time frame: Baseline, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingvild Kjeken, Ph.d study chair
Department of Rheumatology, Diakonhjemmet hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilisation after CMC1-surgery in people with Thumb Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tove Nilsen, MSc (+47 22451500, tove.nilsen@diakonsyk.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.