No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis, duimartrose
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction, the primary outcome, is measured using the validated Dutch version of
the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST). Since no
literature is published yet about the minimally clinically important difference for the D-
QUEST, we defined a value for ourselves. A difference in score on the D-QUEST of more
than 10%, this means 0.5 point difference on the 5-point outcome score, is considered to be
the margin of clinical significance in this study.
Secondary outcome
Secondary outcomes includes pain, measured by a 10-cm visual analogue scale (VAS), and
hand function, measured in terms of grip and pinch strength. In addition, hand function and
symptoms are assessed using the Dutch version of the QuickDASH. Compliance is
quantified by the wearing time per day in hours, reported using a self-reported diary of each
patient. At the end of the two treatment periods, patient preference for one of the two braces
is asked.
Background summary
Rationale: Osteoarthritis (OA) is a degenerative joint disease. The trapeziometacarpal (TMC)
joint is the carpometacarpal joint of the thumb. OA in the TMC joint is a common disease
with a prevalence of 30% to 40% for postmenopausal women. One of the conservative
treatments for TMC OA is a TMC brace. Evidence showed that TMC braces can reduce pain
in TMC OA. Plaster braces are the current conventional treatment of TMC OA in the Reinier
de Graaf hospital. Recently, Manometric developed a 3D printed custom-made brace, based
on a 3D scan of the patient's’ hand. It is made out of light materials and options for
personalisation are provided.
Objective: the aim of this randomised crossover trial is to compare the Manometric TMC
brace with conventional plaster braces in terms of patient satisfaction, pain, hand function,
compliance and patient preference.
Study design: randomised crossover trial with two 4-week study periods and 1-week
washout period in between.
Study population: 52 patients of the Reinier de Graaf Hospital (RdGG) with TMC OA
indicated for brace therapy and who meet all inclusion and none of the exclusion criteria.
Intervention: Patients will receive both the Manometric and plaster brace, since the study
has a crossover design. Patients will be randomised for the order of their treatment.
Primary study outcomes: Patient satisfaction, the primary outcome, measured with the D-
QUEST, is compared between the Manometric and plaster brace. Patient satisfaction,
compliance and patient preference are thought to be superior for the Manometric brace,
compared to the plaster brace. Pain and hand function are thought to obtain equal results
between the two treatments.
Study objective
The hypothesis is that the Manometric brace is superior to conventional plaster braces in
terms of patient satisfaction, compliance and patient preference. For pain and hand function,
no superior outcomes are expected for the Manometric brace compared to the plaster
braces.
Study design
The study consists of two 4-week treatment periods with 1-week washout period in between.
VAS, QuickDASH, pinch and grip score are assessed at baseline and at week 4, 5 and 9.
The D-QUEST is assessed at the 4th and 9th week. Patient preference is asked at the end
of the two treatment periods. Compliance is reported by a daily log during the two 4-week
treatment periods.
Intervention
Patients will receive both the Manometric and the plaster brace for four weeks. Between the
two treatment periods is a one-week washout period.
Inclusion criteria
- Clinical and radiological diagnosis of osteoarthritis (OA) in the TMC joint.
- OA grade 1, 2 of 3 (according to the Kellgren-Lawrence classification system).
- Age ≥18
- Signed informed consent
- Sufficiently able to understand Dutch
In case of bilateral TMC OA, patients who only need a brace for one hand are included, or if
they are willing to wait till after the study for a brace for their second hand. The most
symptomatic side is included in the study, based on clinical and radiological assessment.
Exclusion criteria
- Disease in the affected hand or wrist other than TMC OA that may interfere with treatment or bias
the outcome (OA in radiocarpal joints, underlying inflammatory rheumatic disease, neurovascular disorder affecting
the upper limb, fracture in the past 6 months, significant hand injuries)
- Other (current) therapy for TMC OA (corticosteroid injection in the past 6 months, surgery in the affected TMC joint)
- Insufficient knowledge of the Dutch language
- Mental illness
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7326 |
| NTR-old | NTR7542 |
| Other | METC ZWH : METC 18-109 |