Trapeziometacarpal OsteoarthritisNCT02204995
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4
A study testing Trapeziectomy with LRTI and Trapeziectomy in people with Trapeziometacarpal Osteoarthritis and Thumb Carpometacarpal Osteoarthritis, run by Isala at 1 site in Netherlands.
Trial summary
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis, Thumb Carpometacarpal Osteoarthritis
- What is being tested?
- Trapeziectomy with LRTI and Trapeziectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Sep 2021
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- 40 years of age or more
- Symptomatic trapeziometacarpal osteoarthritis
- Eaton \& Glickel stage 4
Who cannot join
- An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
- Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
- Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- Symptomatic carpal tunnel syndrome in same hand.
- Symptomatic Quervain's tenosynovitis in same hand.
- Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
- Insufficient knowledge of Dutch language.
Trial locations and contacts
1 site in 1 country.
Ramon P. de Wildt, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Isala Hospital
Zwolle, Overijssel
Ramon P. de Wildt, MD, r.p.de.wildt@isala.nl
Ramon P. de Wildt, MD
About this study
Official title: Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.
- Being tested
- Trapeziectomy with LRTI, Trapeziectomy
- Keywords
- Osteoarthritis, Thumb, LRTI, Trapeziectomy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trapeziectomy with LRTIProcedure or surgery
Trapeziectomy with Ligament Reconstruction and Tendon Interposition
TrapeziectomyProcedure or surgery
Trapeziectomy
| Study group | Role | What they receive |
|---|---|---|
| Trapeziectomy with LRTI | Active comparator | Trapeziectomy with Ligament Reconstruction and Tendon Interposition Receives: Procedure: Trapeziectomy with LRTI |
| Trapeziectomy | Active comparator | Trapeziectomy Receives: Procedure: Trapeziectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Measured: 1 year after surgery
Secondary outcomes (7)
Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Measured: 5 years after surgery
Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Measured: 1 and 5 years after surgery
Disabilities of Arm Shoulder and Hand (DASH)
Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
Measured: 1 and 5 years after surgery
Grip strength
Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Measured: 1 and 5 years after surgery
Thumb mobility
Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Measured: 1 and 5 years after surgery
Complications
Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Measured: 1 and 5 years after surgery
Return to work
Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Measured: 1 and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon de Wildt, Isala
- Investigators
- Jeroen H. van Uchelen, MD, Study chair, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204995
- Sponsor's protocol ID
- NL48197.075.14
- Other IDs
- NL48197.075.14
- Status last verified
- Sep 2016
- First submitted
- 29 Jul 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02204995
- Acronym / sponsor ID
- NL48197.075.14
- Keywords
- Osteoarthritis, Thumb, LRTI, Trapeziectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 31 Jul 2014 (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.
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trapeziectomy with LRTI | Active comparator | Procedure: Trapeziectomy with LRTITrapeziectomy with Ligament Reconstruction and Tendon Interposition |
| Trapeziectomy | Active comparator | Procedure: TrapeziectomyTrapeziectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- 40 years of age or more
- Symptomatic trapeziometacarpal osteoarthritis
- Eaton \& Glickel stage 4
Key exclusion criteria (7 listed)
- An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
- Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
- Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- Symptomatic carpal tunnel syndrome in same hand.
- Symptomatic Quervain's tenosynovitis in same 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 |
|---|---|---|
| Trapeziectomy with LRTITrapeziectomy with Ligament Reconstruction and Tendon Interposition | Procedure or surgery | Trapeziectomy with LRTI |
| TrapeziectomyTrapeziectomy | Procedure or surgery | Trapeziectomy |
Primary outcome
Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: 1 year after surgery
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
7 secondary outcomes
Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: 5 years after surgery
Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: 1 and 5 years after surgery
Disabilities of Arm Shoulder and Hand (DASH)
Time frame: 1 and 5 years after surgery
Grip strength
Time frame: 1 and 5 years after surgery
Thumb mobility
Time frame: 1 and 5 years after surgery
Complications
Time frame: 1 and 5 years after surgery
Return to work
Time frame: 1 and 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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.
Ramon P. de Wildt, MD contact
Jeroen H. van Uchelen, MD study chair
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trapeziectomy with LRTI and Trapeziectomy in people with Trapeziometacarpal Osteoarthritis and Thumb Carpometacarpal Osteoarthritis, run by Isala at 1 site in Netherlands.
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 7 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 Sep 2016. 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 Netherlands. 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 Ramon P. de Wildt, MD (r.p.de.wildt@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand Outcomes Questionnaire (MHOQ) (time frame: 1 year after surgery). 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 Sep 2016.