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

Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556515
• Other study ID #: 276-08457c
• Status: Completed
• Phase: N/A
• Start date: November 24, 2008
• Est. completion date: March 16, 2018

Study information

• Verified date: September 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Intervention

Procedure:
• Interpositional arthroplasty (Burton-Pellegrini procedure)
Burton-Pellegrini procedure
• Total joint replacement
Total joint replacement

Device:
• Elektra prosthesis
Elektra prosthesis

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Grip strength	Grip strength, key grip, tip-pinch measured by Jamar dynameter at each follow up	baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months
Other	range of motion	Range of motion measured clinically (Kapandji opposition) and by x-ray (abduction, adduction, extension and flexion) at follow-up	baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months
Other	complications	complications to either treatment form will be registered and published	registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.
Primary	quick-DASH	two-page questionnaire with VAS-scale for pain and function.	Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Secondary	Nelson hospital score	one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528	Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.