The objective of this study is to determine which operation technique is better in terms of pain, physical function, range of motion, strength and complications.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
artrose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Are there subjective differences between the two groups in functional
activities of daily living 12 months after surgery?
The 'Patient Rated Wrist/Hand Evaluation - Dutch Language Version* (PRWHE-dlv)
and the *Disabilities of the arm, Shoulder, and Hand - Dutch Language Version
(DASH-dlv) outcome data collection instruments are used.
Is there significantly less opartion time in the Weilby group.
The operation time is measured as the mean arm tourniquet time used during the
procedure.
Secondary outcome
Differences in pain 12 months after surgery: using the PRWHE-dlv pain subscale.
Differences in strength 12 months after surgery: using E-link
strength-measurement-system maesuring the tip pinch strength, Key pinch
strength, Three-point pinch strength and grip strength.
Differences in mobility of the thumb 12 months after surgery: based on IP joint
flexion/extension; MCP-joint flexion/extension; CMC-joint: palmar abduction
measured using the intermetacarpal distance (IMD: the thumb is placed in full
palmar abduction, the easily identifiable middorsal points on the subcutaneous
surface of the first and second metacarpal heads are marked and the separation
between these is measured in millimetres), opposition measured using the
Kapandji score and extension measured how much the tip of the thumb can be
elevated in millimetres with the hand flat on the table and the thumb in
maximal radial abduction.
Differences in complications 12 months after after surgery: during 12 months
all complications after surgery are scored.
Background summary
Osteoarthritis (OA) at the base of the thumb can cause severe pain, weakness
and/or deformity that significantly interferes with patients activities of
daily living (ADL). It is a common problem, particulary in woman in the fifth
to seventh decades of life. A great variety of operation technique is describes
during the last decades and it is therefore difficult to decide which surgical
technique is indicated for each patient. The overall results of the different
operation techniques in the literature are good, but problems may not have been
noticed due to the relatively short follow-up. Superiority of one technique
over another in terms of pain, physical function, range of motion or strength
is without supporting evidence based on the present literature. We think
however that although superiority at present is without evidence, that there
must be differences between the various surgical procedures, certainly in the
long-term. Therefore more randomized prospective studies comparing different
treatment options should be performed, with standardized methods to measure
preoperative and postoperative outcomes. In this randomised clinical trial we
compare two whidely used operation techniques: the trapeziectomy with the
ligament reconstruction discribed by Weilby and by Burton Pellegrini
Hypothesis: There are no differences between the two groups 12 months after
operation in terms of difficulties during daily life.
Study objective
The objective of this study is to determine which operation technique is better
in terms of pain, physical function, range of motion, strength and
complications.
Study design
a randomised clinical trial.
Intervention
In this randomised clinical trial we compare two whidely used operation
techniques: the trapeziectomy with the ligament reconstruction discribed by
Weilby and by Burton Pellegrini
Study burden and risks
During this study a total of 3 measuremntssessions for each patient is
indicated (preoperative, 3 months postoperative and 12 months postoperative).
Each session takes approximately 30 minutes.
Bosboomstraat 1
3582 KE, Utrecht
NL
Bosboomstraat 1
3582 KE, Utrecht
NL
Listed location countries
Age
Inclusion criteria
woman 40 >= years patient is diagnosed with primary CMC I atrhritis and planed for operation Right and left handed one or both hands are involved CMC I Arthritis Eaton and Glickels classification IV
Exclusion criteria
man: CMC I Eaton and Glickels classification type I, II and III); Operations for CMC I arthritis in history; secondary CMC I arthritis; Muscle, neurological or other problems that could influence the postoperative management. patients who cannot complete the randomisation procedure Less knowledge of the dutch language psychiatry in history
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 | NL25869.100.08 |