Rheumatoid Arthritis (RA)NCT06804356
Poly-L/D-lactide Implant (RegJoint) Versus Tendon Interposition for Trapeziometacarpal Inflammatory Arthritis: a 15-year Follow-up
A study testing Tendon interposition arthroplasty and Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty in people with Rheumatoid Arthritis (RA), run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This is a late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Tendon interposition arthroplasty and Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFinland
- Study dates
- 9 Oct 2019to 2 Apr 2020
- 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
- Patients of the study the results of which are reported in the following article: DOI: 10.3109/2000656X.2012.669202
- Symptomatic end- stage inflammatory arthritis of the trapeziometacarpal joint
- Trapeziometacarpal arthroplasty at Rheumatism Foundation Hospital, Heinola between january 2004 and december 2005
- Signed written informed consent
Who cannot join
- -age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcome of Partial Trapeziectomy With Interposition of Poly-L/D-lactide Scaffold (RegJoint) vs. Autologous Tendon for Inflammatory Trapeziometacarpal Joint Arthritis.
This is a late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland.
For the original study thirty-five patients with symptomatic end-stage inflammatory arthritis of the trapeziometacarpal joint were recruited. All patients signed written informed consent and were randomised to undergo surgery using either tendon interposition or poly-L-D-lactic acid implant interposition arthroplasty of said joint. The study was approved by the Päijät-Häme hospital district ethics committee.
Read more
Results of up to two years of follow-up have been published previously (DOI: 10.3109/2000656X.2012.669202).
For the current study all patients included in the final data analysis of the original study are to be contacted for a late follow-up using the same metrics used in the original study (hand pain and hand function rated on a visual analogue scale, hand strenght measurements, hand range of motion measurements, hand dexterity tests and tests simulating hand function in activities of daily living). Additionally outcomes will be assessed using the Patient Rated Wrist/Hand Evaluation and QuickDASH clinical outcome measurement scores.
Collected follow-up data will be statistically analyzed and a summary will be published in a peer-reviewed scientific journal.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Tendon interposition arthroplasty, Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon interposition arthroplastyProcedure or surgery
Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces.
Poly-L-D-lactic acid implant (RegJoint) interposition arthroplastyProcedure or surgery
Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Tendon interposition arthroplasty | Active comparator | Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces. Receives: Procedure: Tendon interposition arthroplasty |
| Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty | Active comparator | Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces. Receives: Procedure: Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand pain
Pain of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes no pain at all and 100mm denotes worst pain imaginable.
Measured: Approximately 15 years from enrollment
Hand function
Function of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes normal hand function and 100mm denotes the hand not functioning at all.
Measured: Approximately 15 years from enrollment
Hand grip strength
Power grip strength (in kg) measured using a jamar hand dynamometer. Key pinch and tip pinch strength (in kg) mearured using a mechanical pinch gauge.
Measured: Approximately 15 years from enrollment
QuickDASH score
The Disabilities of the Arm, Shoulder, and Hand (DASH) is a clinical outcome measure questionnaire consisting of thirty questions and has been validated several times. The QuickDASH score includes eleven of those questions and has been validated as well. Both scores are used to evaluate upper limb function and symptoms during the previous week.
Measured: The previous week before approximately 15 years from enrollment
Hand range of motion
Active range of motion for following joints / parts of the hand: trapeziometacarpal joint radial abduction, thumb metacarpophalangeal joint extension and flexion, thumb interphalangeal joint extension and flexion.
Measured: Approximately 15 years from enrollment
Box and block dexterity test
The Box and block dexterity consists of a rectangular box with a central dividing wall. The box is set on a table in front of the patient in a lengthwise orientation with the dividing wall at the patients midline. At the beginning of the test all 150 wooden cubes each 2,5cm are placed in the compartment on the side of the hand being tested. The test performed by moving as many 2,5cm wooden cubes one by one by hand from one box to another within 60 seconds as possible. Before the actual test the patient practices performing the test for 15 seconds with each hand,
Measured: Approximately 15 years from enrollment
Simulated activities of daily living tests
Decanting water from a jug gripping the jug by its handle into a glass / cup. Decanting water from a glass / cup into jug gripping the glass with a palm grip. Cutting medical putty disc with knife and fork simulating cutting food on a plate.
Picking up a wooden bead approximately 1cm in diameter using a pinch grip. The test is repeated four times for each hand so that the patient always uses their thumb but the opposing finger is different each time.
Grading for all tests: Normal grip / adapted grip / unable to perform.
Measured: Approximately 15 years from enrollment
Radiological results
Trapeziometacarpal joint (sub)luxation, joint trapeziometacarpal joint space height and bone destruction adjacent to the trapeziometarcpal joint using posterior to anteriot as well as lateral plain radiographs.
Measured: Approximately 15 years from enrollment
Patient Rated Wrist/Hand Evaluation clinical outcome measure
The Patient-Rated Wrist and Hand Evaluation questionnaire is a region specific, patient reported outcome measure that aims to evaluate pain and disability of the wrist and hand. In one question the patient is asked about their hand / wrist today, while in fifteen questions the patient is asked about their hand / wrist this week. The score has been validated multiple times.
Measured: The previous week before approximately 15 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start9 Oct 2019
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mikael Hackenberg, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804356
- Sponsor's protocol ID
- HUS/575/2019
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present we have no plan to share IPD as local legislature and the study protocol do not allow us to do so. If other researchers were to ask us to share IPD, we would be happy to apply permission to do so from our institution.
Publications
Tiihonen RP, Skytta ET, Kaarela K, Ikavalko M, Belt EA. Reconstruction of the trapeziometacarpal joint in inflammatory joint disease using interposition of autologous tendon or poly-L-D-lactic acid implants: a prospective clinical trial. J Plast Surg Hand Surg. 2012 Apr;46(2):113-9. doi: 10.3109/2000656X.2012.669202.
PubMed 22471260
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Partial Trapeziectomy With Interposition of Poly-L/D-lactide Scaffold (RegJoint) vs. Autologous Tendon for Inflammatory Trapeziometacarpal Joint Arthritis.
- ClinicalTrials.gov ID
- NCT06804356
- Acronym / sponsor ID
- HUS/575/2019
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 3 Feb 2025 (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 late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland.
For the original study thirty-five patients with symptomatic end-stage inflammatory arthritis of the trapeziometacarpal joint were recruited. All patients signed written informed consent and were randomised to undergo surgery using either tendon interposition or poly-L-D-lactic acid implant interposition arthroplasty of said joint. The study was approved by the Päijät-Häme hospital district ethics committee.
Results of up to two years of follow-up have been published previously (DOI: 10.3109/2000656X.2012.669202).
For the current study all patients included in the final data analysis of the original study are to be contacted for a late follow-up using the same metrics used in the original study (hand pain and hand function rated on a visual analogue scale, hand strenght measurements, hand range of motion measurements, hand dexterity tests and tests simulating hand function in activities of daily living). Additionally outcomes will be assessed using the Patient Rated Wrist/Hand Evaluation and QuickDASH clinical outcome measurement scores.
Collected follow-up data will be statistically analyzed and a summary will be published in a peer-reviewed scientific journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tendon interposition arthroplasty | Active comparator | Procedure: Tendon interposition arthroplastyTrapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces. |
| Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty | Active comparator | Procedure: Poly-L-D-lactic acid implant (RegJoint) interposition arthroplastyTrapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of the study the results of which are reported in the following article: DOI: 10.3109/2000656X.2012.669202
- Symptomatic end- stage inflammatory arthritis of the trapeziometacarpal joint
- Trapeziometacarpal arthroplasty at Rheumatism Foundation Hospital, Heinola between january 2004 and december 2005
- Signed written informed consent
Key exclusion criteria (1 listed)
- -age less than 18 years
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 |
|---|---|---|
| Tendon interposition arthroplastyTrapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces. | Procedure or surgery | Tendon interposition arthroplasty |
| Poly-L-D-lactic acid implant (RegJoint) interposition arthroplastyTrapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces. | Procedure or surgery | Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty |
Primary outcome
Hand pain
Time frame: Approximately 15 years from enrollment
Pain of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes no pain at all and 100mm denotes worst pain imaginable.
Hand function
Time frame: Approximately 15 years from enrollment
Function of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes normal hand function and 100mm denotes the hand not functioning at all.
Hand grip strength
Time frame: Approximately 15 years from enrollment
Power grip strength (in kg) measured using a jamar hand dynamometer. Key pinch and tip pinch strength (in kg) mearured using a mechanical pinch gauge.
QuickDASH score
Time frame: The previous week before approximately 15 years from enrollment
The Disabilities of the Arm, Shoulder, and Hand (DASH) is a clinical outcome measure questionnaire consisting of thirty questions and has been validated several times. The QuickDASH score includes eleven of those questions and has been validated as well. Both scores are used to evaluate upper limb function and symptoms during the previous week.
Hand range of motion
Time frame: Approximately 15 years from enrollment
Active range of motion for following joints / parts of the hand: trapeziometacarpal joint radial abduction, thumb metacarpophalangeal joint extension and flexion, thumb interphalangeal joint extension and flexion.
Box and block dexterity test
Time frame: Approximately 15 years from enrollment
The Box and block dexterity consists of a rectangular box with a central dividing wall. The box is set on a table in front of the patient in a lengthwise orientation with the dividing wall at the patients midline. At the beginning of the test all 150 wooden cubes each 2,5cm are placed in the compartment on the side of the hand being tested. The test performed by moving as many 2,5cm wooden cubes one by one by hand from one box to another within 60 seconds as possible. Before the actual test the patient practices performing the test for 15 seconds with each hand,
Simulated activities of daily living tests
Time frame: Approximately 15 years from enrollment
Decanting water from a jug gripping the jug by its handle into a glass / cup. Decanting water from a glass / cup into jug gripping the glass with a palm grip. Cutting medical putty disc with knife and fork simulating cutting food on a plate. Picking up a wooden bead approximately 1cm in diameter using a pinch grip. The test is repeated four times for each hand so that the patient always uses their thumb but the opposing finger is different each time. Grading for all tests: Normal grip / adapted grip / unable to perform.
Radiological results
Time frame: Approximately 15 years from enrollment
Trapeziometacarpal joint (sub)luxation, joint trapeziometacarpal joint space height and bone destruction adjacent to the trapeziometarcpal joint using posterior to anteriot as well as lateral plain radiographs.
Patient Rated Wrist/Hand Evaluation clinical outcome measure
Time frame: The previous week before approximately 15 years from enrollment
The Patient-Rated Wrist and Hand Evaluation questionnaire is a region specific, patient reported outcome measure that aims to evaluate pain and disability of the wrist and hand. In one question the patient is asked about their hand / wrist today, while in fifteen questions the patient is asked about their hand / wrist this week. The score has been validated multiple times.
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 3 Feb 2025.
- Background: PubMed 22471260Tiihonen RP, Skytta ET, Kaarela K, Ikavalko M, Belt EA. Reconstruction of the trapeziometacarpal joint in inflammatory joint disease using interposition of autologous tendon or poly-L-D-lactic acid implants: a prospective clinical trial. J Plast Surg Hand Surg. 2012 Apr;46(2):113-9. doi: 10.3109/2000656X.2012.669202.
- Individual participant dataSharing planned: Undecided. At present we have no plan to share IPD as local legislature and the study protocol do not allow us to do so. If other researchers were to ask us to share IPD, we would be happy to apply permission to do so from our institution.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon interposition arthroplasty and Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty in people with Rheumatoid Arthritis (RA), run by Helsinki University Central Hospital at 1 site in Finland.
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 1 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 3 Feb 2025. 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 Finland. 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?
Hand pain (time frame: Approximately 15 years from enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804356, which also lists 1 linked publication.
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 3 Feb 2025.