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Completed

NCT Number: NCT02556515

Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial

Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.

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Key information

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0021, Norway

About this study

Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.

Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy

Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength

Complications are registered.

The patients are observed for two years and the investigators aim to include a total of 40 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CMC 1 arthritis
  • Pain and dysfunction
  • Adult patients
  • General good health

Exclusion criteria

  • Pregnancy
  • STT arthritis (CT scan preoperatively for all patients)
  • Other injuries in thumb/hand

Treatment and study plan

Interpositional arthroplasty (Burton-Pellegrini procedure)

Procedure

Burton-Pellegrini procedure

Total joint replacement

Procedure

Total joint replacement

Other names: Elektra prosthesis (Dijon, France)

Elektra prosthesis

Device

Elektra prosthesis

Primary outcomes

  1. quick-DASH

    Time frame: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.

    two-page questionnaire with VAS-scale for pain and function.

Secondary outcomes

  1. Nelson hospital score

    Time frame: Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.

    one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528

Other outcomes

  1. Grip strength

    Time frame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months

    Grip strength, key grip, tip-pinch measured by Jamar dynameter at each follow up

  2. range of motion

    Time frame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months

    Range of motion measured clinically (Kapandji opposition) and by x-ray (abduction, adduction, extension and flexion) at follow-up

  3. complications

    Time frame: registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.

    complications to either treatment form will be registered and published

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2015
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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