Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Conditions
Keywords
CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement
Brief 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.
Detailed 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.
Interventions
PROCEDUREInterpositional arthroplasty (Burton-Pellegrini procedure)
Burton-Pellegrini procedure
PROCEDURETotal joint replacement
Total joint replacement
DEVICEElektra prosthesis
Elektra prosthesis
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quick-DASH | 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
| Measure | Time frame | Description |
|---|---|---|
| Nelson hospital score | 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
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 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 |
| range of motion | 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 |
| complications | registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months. | complications to either treatment form will be registered and published |
Countries
Norway
Outcome results
None listed