To demonstrate that immediate fixation leads to a shorter total rehabilitation period and to less stiffness at final follow-up after SL reconstruction.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In both groups, mobility (flexion and extension, E-link) will be assessed at
baseline, six weeks and three, six and twelve months postoperatively.
Secondary outcome
In both groups, pain intensity (VAS), strength (Jamar grip strength) and
function (PRWHE-DLV, quickDASH) will be assessed at baseline, six weeks and
three, six and twelve months postoperatively.
Background summary
Following scapho-lunate ligament (SL) reconstruction, a six month
rehabilitation period is required. In the standard procedure, SL and SC are
secured with K-wires and the wrist is immobilized for six weeks in an upper-arm
cast. Applying bio-tenodesis screws for immediate fixation of the tendon graft
to the scaphoid and lunate enables skipping the six week K-wire and cast
immobilization. Our hypothesis is that the immediate fixation leads to a
shorter total rehabilitation period and to less stiffness at final follow-up
after SL reconstruction.
Study objective
To demonstrate that immediate fixation leads to a shorter total rehabilitation
period and to less stiffness at final follow-up after SL reconstruction.
Study design
Randomized controlled trial.
Intervention
Fifty patients will be included in this study. Through randomization, 25
patients will be treated by means of the standard procedure and 25 patients
will be treated with the immediate fixation technique.
Study burden and risks
The duration and burden of the operation will be the same in each group. The
standard procedure requires 6 weeks immobilisation, whereas patients in the
immediate fixation technique group will be immobilised for one week. The
standard rehabilitation period has a 6 month duration and taking part in the
study puts no extra burden on patients in this six month period. The final
assessment, however, will be at twelve months requiring an extra visit to the
hospital.
van Swietenplein 1
Groningen 9728NT
NL
van Swietenplein 1
Groningen 9728NT
NL
Listed location countries
Age
Inclusion criteria
Age 18 to 65 years
Arthroscopically confirmed SL injury of at least Geissler 2
Exclusion criteria
Presence of SLAC (arthritis)
Another condition affecting the function of the diseased or contralateral
extremity
Inability to speak the Dutch language
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 | NL83629.042.23 |