Osteoarthritis ThumbNCT06370312
Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints
An observational study of Osteoarthritis Thumb and Osteoarthritis, Knee, run by Region Skane at 2 sites in Sweden.
Trial summary
The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Osteoarthritis Thumb, Osteoarthritis, Knee, Metabolic Disease
- What is being tested?
- Trapeziectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 1 May 2024to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients fulfilling the eligibility criteria and are scheduled for surgery at any of two study centres; Department of hand surgery, Skane university hospital or Aleris Malmö Arena (private clinic), due to symptomatic thumb basal joint OA are invited to participate. Indications for surgery at these to clinics are; 1) persistent pain and pain at rest, 2) have tried conservative treatment with inadequate effect.
Who may be able to join
- Men and women age ≥ 25 years
- Radiologically confirmed and symptomatic thumb basal joint osteoarthritis (OA) planned for trapeziectomy
Who cannot join
- Previous surgery to the affected thumb basal joint
- Post-traumatic thumb basal joint OA
- Rheumatoid arthritis or other chronic inflammatory arthritis, history of psoriasis affecting joints, gout or pseudogout
- Ongoing infection in the hand or wrist
- Inability to co-operate with the follow-up protocol or to assimilate information about the study protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
- Systemic or intra-articular glucocorticoids or intraarticular platelet-rich plasma or hyaluronic acid injections in the affected joint within 3 months prior to enrollment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
My von Walter, MD contact
Sweden2 sites, 2 recruiting
- Not yet recruiting
Department of Hand Surgery, Skane University Hospital
Malmö, Skåne County, 20502
Elisabeth Brogren, MD, PhD, 040-331723, elisabeth.brogren@med.lu.se
- Recruiting
Aleris Specialistläkare Hyllie
Malmö, Skåne County, 21532
My Winblad von Walter, MD, 010-1690000, my@aleris.se
Anders Kjellin, MD, 0431-371715, anders.kjellin@aleris.se
About this study
Official title: Analysis of Synovial Fluid, Bone and Articular Cartilage From Osteoarthritic First Carpometacarpal Joints in Relationship to Metabolic Risk Factors and Patient-reported Hand Function
The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid.
Read the detailed description
Patients scheduled for trapeziectomy on the basis of thumb basal joint osteoarthritis will be asked to participate. Synovial fluid from the thumb basal joint is aspirated before the joint is opened. The trapezium bone and cartilage is harvested. Blood samples to evaluated lipid profile and glucose intolerance is drawn. Blood pressure and measurements of obesity is taken. Patients are also examined at baseline and 1 year postop with grip strength, pinch strength, range of thumb motion and asked to fill in patient-rated outcome measures; QuickDASH and NRS pain.
- Being tested
- Trapeziectomy
- Medical subject headings
- Osteoarthritis, Knee, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrapeziectomyProcedure or surgery
Patients scheduled for trapeziectomy due to thumb basal joint osteoarthritis are invited to participate. Synovial fluid is aspirated before the joint is opened. Bone and cartilage are collected. Blood samples are obtained preop. Patients are measured with grip strength, pinch strength, range of thumb motion, body mass index, central obesity and blood pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cholesterol levels
Blood samples are drawn from the patients and analysed according to Swedish laboratory standards
Measured: Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Brogren, MD, PhD, Principal investigator, Department of hand surgery, Region Skåne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370312
- Sponsor's protocol ID
- 2023-07921-01
- Other IDs
- 2023
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Synovial Fluid, Bone and Articular Cartilage From Osteoarthritic First Carpometacarpal Joints in Relationship to Metabolic Risk Factors and Patient-reported Hand Function
- ClinicalTrials.gov ID
- NCT06370312
- Acronym / sponsor ID
- 2023-07921-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Apr 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.
The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid.
Detailed description
Patients scheduled for trapeziectomy on the basis of thumb basal joint osteoarthritis will be asked to participate. Synovial fluid from the thumb basal joint is aspirated before the joint is opened. The trapezium bone and cartilage is harvested. Blood samples to evaluated lipid profile and glucose intolerance is drawn. Blood pressure and measurements of obesity is taken. Patients are also examined at baseline and 1 year postop with grip strength, pinch strength, range of thumb motion and asked to fill in patient-rated outcome measures; QuickDASH and NRS pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients fulfilling the eligibility criteria and are scheduled for surgery at any of two study centres; Department of hand surgery, Skane university hospital or Aleris Malmö Arena (private clinic), due to symptomatic thumb basal joint OA are invited to participate. Indications for surgery at these to clinics are; 1) persistent pain and pain at rest, 2) have tried conservative treatment with inadequate effect.
Key inclusion criteria (2 listed)
- Men and women age ≥ 25 years
- Radiologically confirmed and symptomatic thumb basal joint osteoarthritis (OA) planned for trapeziectomy
Key exclusion criteria (6 listed)
- Previous surgery to the affected thumb basal joint
- Post-traumatic thumb basal joint OA
- Rheumatoid arthritis or other chronic inflammatory arthritis, history of psoriasis affecting joints, gout or pseudogout
- Ongoing infection in the hand or wrist
- Inability to co-operate with the follow-up protocol or to assimilate information about the study protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
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 |
|---|---|---|
| TrapeziectomyPatients scheduled for trapeziectomy due to thumb basal joint osteoarthritis are invited to participate. Synovial fluid is aspirated before the joint is opened. Bone and cartilage are collected. Blood samples are obtained preop. Patients are measured with grip strength, pinch strength, range of thumb motion, body mass index, central obesity and blood pressure. | Procedure or surgery | – |
Primary outcome
Serum cholesterol levels
Time frame: Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)
Blood samples are drawn from the patients and analysed according to Swedish laboratory standards
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. No sharing
Related trials for Osteoarthritis Thumb
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
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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.
My von Walter, MD contact
Elisabeth Brogren, MD, PhD principal investigator
Department of hand surgery, Region Skåne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Thumb and Osteoarthritis, Knee, run by Region Skane at 2 sites in Sweden.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Brogren, MD, PhD (+46 40331723, elisabeth.brogren@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cholesterol levels (time frame: Serum cholesterol levels are drawn at baseline (i.e. the day of 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 25 Jun 2025.