Clinical trial NCT06370312: Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis Thumb
Osteoarthritis, Knee
Metabolic Disease
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Men and women age ≥ 25 years
* Radiologically confirmed and symptomatic thumb basal joint osteoarthritis (OA) planned for trapeziectomy

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serum cholesterol levels
timeFrame: Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Hand Surgery, Skane University Hospital
state: Skåne
city: Malmö
country: Sweden
facility: Aleris Specialistläkare Hyllie
state: Skåne
Study officials:
affiliation: Department of hand surgery, Region Skåne
name: Elisabeth Brogren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: