Osteoarthrosis of the Carpometacarpal Joint of the ThumbNCT02556515
Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial
A study testing Interpositional arthroplasty (Burton-Pellegrini procedure), Total joint replacement and Elektra prosthesis in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- What is being tested?
- Interpositional arthroplasty (Burton-Pellegrini procedure), Total joint replacement and Elektra prosthesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 24 Nov 2008to 16 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CMC 1 arthritis
- Pain and dysfunction
- Adult patients
- General good health
Who cannot join
- Pregnancy
- STT arthritis (CT scan preoperatively for all patients)
- Other injuries in thumb/hand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb
Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.
Read the detailed description
Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.
Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy
Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength
Complications are registered.
The patients are observed for two years and the investigators aim to include a total of 40 patients.
- Being tested
- Interpositional arthroplasty (Burton-Pellegrini procedure), Total joint replacement, Elektra prosthesis
- Keywords
- CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpositional arthroplasty (Burton-Pellegrini procedure)Procedure or surgery
Burton-Pellegrini procedure
Total joint replacementProcedure or surgery
Also called Elektra prosthesis (Dijon, France)
Total joint replacement
Elektra prosthesisDevice
Elektra prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Trapeziektomi and ligament interposition | Active comparator | Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure) Receives: Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure) |
| Total joint replacement | Experimental | Elektra CMC1 uncemented prosthesis Elektra prosthesis Receives: Procedure: Total joint replacement; Device: Elektra prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
quick-DASH
two-page questionnaire with VAS-scale for pain and function.
Measured: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Secondary outcomes (1)
Nelson hospital score
one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528
Measured: Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start24 Nov 2008
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthrosis of the Carpometacarpal Joint of the ThumbStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Thorkildsen, Oslo University Hospital
- Investigators
- Rasmus Thorkildsen, MBBS(Bsc), Principal investigator, Hand- and microsurgical unit, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556515
- Sponsor's protocol ID
- 276-08457c
- Status last verified
- Sep 2018
- First submitted
- 17 Feb 2014
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb
- ClinicalTrials.gov ID
- NCT02556515
- Acronym / sponsor ID
- 276-08457c
- Keywords
- CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2008 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 22 Sep 2015 (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.
Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.
Detailed description
Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.
Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy
Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength
Complications are registered.
The patients are observed for two years and the investigators aim to include a total of 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trapeziektomi and ligament interposition | Active comparator | Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure) |
| Total joint replacement | Experimental | Procedure: Total joint replacement, Device: Elektra prosthesisElektra CMC1 uncemented prosthesis Elektra prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CMC 1 arthritis
- Pain and dysfunction
- Adult patients
- General good health
Key exclusion criteria (3 listed)
- Pregnancy
- STT arthritis (CT scan preoperatively for all patients)
- Other injuries in thumb/hand
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 |
|---|---|---|
| Interpositional arthroplasty (Burton-Pellegrini procedure)Burton-Pellegrini procedure | Procedure or surgery | Trapeziektomi and ligament interposition |
| Total joint replacementAlso: Elektra prosthesis (Dijon, France)Total joint replacement | Procedure or surgery | Total joint replacement |
| Elektra prosthesisElektra prosthesis | Device | Total joint replacement |
Primary outcome
quick-DASH
Time frame: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
two-page questionnaire with VAS-scale for pain and function.
1 secondary outcome
Nelson hospital score
Time frame: Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Rasmus Thorkildsen, MBBS(Bsc) principal investigator
Hand- and microsurgical unit, Oslo University 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 Interpositional arthroplasty (Burton-Pellegrini procedure), Total joint replacement and Elektra prosthesis in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Oslo University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quick-DASH (time frame: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.). 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 25 Sep 2018.