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Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility

T

Töölö Hospital

Status

Enrolling

Conditions

Thumb Osteoarthritis
Quality of Life
Arthritis
Arthropathy

Treatments

Procedure: Trapeziectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04826380
3163/2020

Details and patient eligibility

About

A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy

Enrollment

150 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Eaton-Glickel >2 arhritis
  • Symptom duration >3 months
  • Pain VAS >30mm
  • No significant comorbidities, ASA I-II
  • Fluent in Finnish language

Exclusion criteria

  • Eaton-Glickel <2
  • Duration of symptoms <3 months
  • VAS <30mm
  • ASA >II
  • Inflammatory joint disease
  • Systemic corticosteroid or immunomodulatory medication
  • Upper limb symptoms not explained with CMC I artritis
  • Heavy smoking (> 20 cigarettes per day)
  • Alcohol or drug abuse
  • Neurological condition affecting upper limb function
  • Other ipsilateral upper limb condition requiring surgery

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Trapeziectomy
Other group
Description:
Simple trapeziectomy for treating CMC I arthritis
Treatment:
Procedure: Trapeziectomy
Conservative
No Intervention group
Description:
Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis

Trial contacts and locations

1

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Central trial contact

Samuli Aspinen, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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