CMC-1 OsteoarthritisNCT06290986
Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis
A study testing Pyrocardan® implant and Ligament reconstruction and tendon interposition (LRTI) in people with CMC-1 Osteoarthritis and Trapeziometacarpal Osteoarthritis, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- CMC-1 Osteoarthritis, Trapeziometacarpal Osteoarthritis
- What is being tested?
- Pyrocardan® implant and Ligament reconstruction and tendon interposition (LRTI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Sep 2022to 30 Sep 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the trapeziometacarpal joint of the thumb.
- Insufficient effect of non-surgical treatment with symptoms severe enough to justify surgical treatment.
- ASA score 1-3, physically fit for surgery and rehabilitation
Who cannot join
- Below 40 years of age
- Cognitive or linguistic impairment
- Osteoarthritis in other carpal bones (STT OA and others)
- Previous surgical treatment in the trapeziometacarpal joint.
- Patients with rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Hellerup, 2900
Jens Jørgsholm, MD, +4551339705, Jens.bertel.joergsholm.01@regionh.dk
Rasmus Wejnold Jørgensen, MD, PhD, +4538673315, rasmus.wejnold.joergensen@regionh.dk
About this study
Official title: Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - A Randomized Controlled Trial
This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years.
Read the detailed description
The Pyrocardan® is designed by Philippe Bellemere and has been used since 2009. It is a biconcave-shaped CMC-1 interposition implant. The biconcave shape converts the CMC-1 saddle joint into a cardan-like joint. The implant is suitable for Eaton grade 2 or 3. The advantages compared to LRTI are believed to be preserved thumb length, faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint.
Most recently results from the Bellemere group in 2020 have shown excellent results in 103 patients 5 years following surgery. A study by Gerace et al. reported a significant improvement in pain, QuickDASH and strength, with a revision rate of 4% and a survival rate at 96% at 5 years of follow-up. A recent review from 2022 reported 97% survival rate at 4 years and an estimated survival rate of 95% at 7 years from surgery.
The purpose of this randomized study is to compare Pyrocardan® implant (intervention group 1.) with ligament reconstruction and tendon interposition (LRTI), (intervention group 2.) in patients treated with mild to moderate CMC-1 osteoarthritis. There is to our knowledge no randomized controlled trial (RCT) studies on Pyrocardan® implant.
Hypothesis Pyrocardan® can provide a faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint compared to LRTI.
All patients referred to the Orthopedic Surgery Department, Hand Surgery Unit at Copenhagen University Hospital in Herlev/Gentofte with CMC-1 OA with pain in the thumb base and suspected degenerative changes and indication of surgical treatment will be eligible for inclusion. The following criteria will result in exclusion from participation in the study: Age under 40, cognitive or linguistic impairment, presence of osteoarthritis in other carpal bones, previous surgery in trapeziometacarpal joint or diagnosis of rheumatoid arthritis.
A total of 64 patients will be included in the study based on a sample size calculation using the MCID of Q-DASH. This number will also account for a maximum dropout rate of 18%. The study will be a randomized clinical trial (RCT), where participants will be assigned to one of the two surgical techniques through a randomized process. Patients will be monitored to evaluate any differences between the techniques. The primary outcome measure will be the patient-reported outcome using the QuickDASH assessment. Secondary outcomes will include pain relief, questionnaires, radiographic changes, range of motion and strength (functional outcome), readmission rates, complications, and revisions. Patients will undergo examinations before the surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the surgery. Additionally, patients will be contacted 5 and 10 years following the surgery for further follow-up. The study will be conducted as a single-center study and all procedures will be performed by one of three experienced hand surgeons.
- Being tested
- Pyrocardan® implant, Ligament reconstruction and tendon interposition (LRTI)
- Keywords
- Hand Osteoarthritis, Pyrocardan, CMC-1, Trapeziometacarpal Osteoarthritis, Osteoarthritis, Joint Diseases
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrocardan® implantProcedure or surgery
Biconcave-shaped CMC-1 interposition implant
Ligament reconstruction and tendon interposition (LRTI)Procedure or surgery
Weilby slightly modified as described by Burton and Pellegrini
| Study group | Role | What they receive |
|---|---|---|
| Pyrocardan® implant | Active comparator | Not described Receives: Procedure: Pyrocardan® implant |
| Ligament reconstruction and tendon interposition (LRTI) | Active comparator | Not described Receives: Procedure: Ligament reconstruction and tendon interposition (LRTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcome: QuickDASH
Quick version of the Disability of the arm, shoulder and hand questionnaire (QuickDASH):
0-100 p, higher score = more disability
Measured: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Secondary outcomes (4)
Patient-reported outcome
VAS (rest), VAS (activity), 0-10 p, higher score = more pain.
Satisfaction scores: 1-5 p, higher score = more satisfied.
Measured: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Strength measurements
Hand grip and Pinch (Kg)
Measured: 6 weeks, 3 months, 6 months, 1 year, 2 years
Radiographs
Measured subsidence on radiographs
Measured: 6 weeks
Return to occupation
Postoperative sick leave
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start26 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMC-1 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Joergsholm, Herlev and Gentofte Hospital
- Investigators
- Jens Joergsholm, MD, Principal investigator, Herlev Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290986
- Sponsor's protocol ID
- Pyrocardan® RCT
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06290986
- Acronym / sponsor ID
- Pyrocardan® RCT
- Keywords
- Hand Osteoarthritis, Pyrocardan, CMC-1, Trapeziometacarpal Osteoarthritis, Osteoarthritis, Joint Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- 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.
This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years.
Detailed description
The Pyrocardan® is designed by Philippe Bellemere and has been used since 2009. It is a biconcave-shaped CMC-1 interposition implant. The biconcave shape converts the CMC-1 saddle joint into a cardan-like joint. The implant is suitable for Eaton grade 2 or 3. The advantages compared to LRTI are believed to be preserved thumb length, faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint.
Most recently results from the Bellemere group in 2020 have shown excellent results in 103 patients 5 years following surgery. A study by Gerace et al. reported a significant improvement in pain, QuickDASH and strength, with a revision rate of 4% and a survival rate at 96% at 5 years of follow-up. A recent review from 2022 reported 97% survival rate at 4 years and an estimated survival rate of 95% at 7 years from surgery.
The purpose of this randomized study is to compare Pyrocardan® implant (intervention group 1.) with ligament reconstruction and tendon interposition (LRTI), (intervention group 2.) in patients treated with mild to moderate CMC-1 osteoarthritis. There is to our knowledge no randomized controlled trial (RCT) studies on Pyrocardan® implant.
Hypothesis Pyrocardan® can provide a faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint compared to LRTI.
All patients referred to the Orthopedic Surgery Department, Hand Surgery Unit at Copenhagen University Hospital in Herlev/Gentofte with CMC-1 OA with pain in the thumb base and suspected degenerative changes and indication of surgical treatment will be eligible for inclusion. The following criteria will result in exclusion from participation in the study: Age under 40, cognitive or linguistic impairment, presence of osteoarthritis in other carpal bones, previous surgery in trapeziometacarpal joint or diagnosis of rheumatoid arthritis.
A total of 64 patients will be included in the study based on a sample size calculation using the MCID of Q-DASH. This number will also account for a maximum dropout rate of 18%. The study will be a randomized clinical trial (RCT), where participants will be assigned to one of the two surgical techniques through a randomized process. Patients will be monitored to evaluate any differences between the techniques. The primary outcome measure will be the patient-reported outcome using the QuickDASH assessment. Secondary outcomes will include pain relief, questionnaires, radiographic changes, range of motion and strength (functional outcome), readmission rates, complications, and revisions. Patients will undergo examinations before the surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the surgery. Additionally, patients will be contacted 5 and 10 years following the surgery for further follow-up. The study will be conducted as a single-center study and all procedures will be performed by one of three experienced hand surgeons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyrocardan® implant | Active comparator | Procedure: Pyrocardan® implant |
| Ligament reconstruction and tendon interposition (LRTI) | Active comparator | Procedure: Ligament reconstruction and tendon interposition (LRTI) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis of the trapeziometacarpal joint of the thumb.
- Insufficient effect of non-surgical treatment with symptoms severe enough to justify surgical treatment.
- ASA score 1-3, physically fit for surgery and rehabilitation
Key exclusion criteria (5 listed)
- Below 40 years of age
- Cognitive or linguistic impairment
- Osteoarthritis in other carpal bones (STT OA and others)
- Previous surgical treatment in the trapeziometacarpal joint.
- Patients with rheumatoid arthritis
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 |
|---|---|---|
| Pyrocardan® implantBiconcave-shaped CMC-1 interposition implant | Procedure or surgery | Pyrocardan® implant |
| Ligament reconstruction and tendon interposition (LRTI)Weilby slightly modified as described by Burton and Pellegrini | Procedure or surgery | Ligament reconstruction and tendon interposition (LRTI) |
Primary outcome
Patient-reported outcome: QuickDASH
Time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Quick version of the Disability of the arm, shoulder and hand questionnaire (QuickDASH): 0-100 p, higher score = more disability
4 secondary outcomes
Patient-reported outcome
Time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Strength measurements
Time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years
Radiographs
Time frame: 6 weeks
Return to occupation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Study on Basal Joint Arthritis Prospective
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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.
Jens Joergsholm, MD principal investigator
Herlev Gentofte 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 Pyrocardan® implant and Ligament reconstruction and tendon interposition (LRTI) in people with CMC-1 Osteoarthritis and Trapeziometacarpal Osteoarthritis, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 5 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 4 Mar 2024. 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 Denmark. 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 Jens Jørgsholm, MD (+4551339705, Jens.bertel.joergsholm.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome: QuickDASH (time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years). 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 4 Mar 2024.