To determine the degree of recurrence of contractures in the thumb, caused by Dupuytren'Disease after treatment with CCH
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Contractures are measured with a goniometer. Baseline is the measurement of
ROM in degrees of the extension deficit as measured 30 days after the
injection with CCH . We measure the mean increase of contracture and the
deviation.
Secondary outcome
Not applicable
Background summary
Between september 2012 and January 2014 12 subjects received an injection with
Collagenase Clostridium Histolyticum (CCH) in the thumb to treat contractures
caused by Dupuytren's Disease. This took place in the study "A Prospective
clinical study on the efficacy of collagenase clostridium histolyticum (CCH)
injections in the thumb and first web space contractures in Dupuytren's
Disease". The treatment resulted in a significant improvement of Range of
Motion in the study group. In this follow-up study we want to determine if and
how much what the recurrence there will be in the thumb . Because the disease
may develop slowly, we want to do this over a period of 6 years.
Study objective
To determine the degree of recurrence of contractures in the thumb, caused by
Dupuytren'Disease after treatment with CCH
Study design
An observational study
Study burden and risks
The subject has to travel to the UMCG to have the position of his thumb
measured. Subjects came from all over the country.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
12 subjects who had CCH treatment in 14 thumbs during previous study.
Exclusion criteria
Subjects who had new treatment of the thumb or first webspace since their treatment with CCH will be excluded
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54805.042.15 |
| Other | no number yet |