To assess the effects on knee pain, function, quality of life and change in structural features with respect to cartilage and subchondral bone of osteotomy surgery after one year of follow-up compared to the effects of treatment with an orthopaedic…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the knee pain after one year of follow-up
assessed with the pain subscale of the Knee injury and Osteoarthritis Outcome
Score.
Secondary outcome
Secondary endpoints in the study are difference in the following outcome
parameters: pain severity (Numerical Rating scale; NRS), other KOOS subscales,
Hospital for Special Surgery scale (HSS), quality of life (EQ5-D), and physical
activity scores (SQUASH). Other outcomes are pain medication use, side effects,
difference in direct and indirect costs (PRODISC), change in cartilage quality
of the medial and lateral compartment of the tibia (semi-quantitative and
quantitative MRI scores), changes of bone mineral density of the medial and
lateral compartment of the tibia (DXA scan), mechanical axis of the limb (whole
leg radiographs) and serum and urine (osteoarthritis biomarker, genetic
profile) will be collected and bone remodelling activity (SPECT CT scan).
Background summary
To postpone joint replacement surgery for patients with uni-compartiment
osteoarthritis an osteotomy surgery or an unloader kneebrace are effective
treatment options. Till date the effect on symptoms and structural progression
of this non-surgical knee brace with the surgical osteotomy has not been
compared.
Study objective
To assess the effects on knee pain, function, quality of life and change in
structural features with respect to cartilage and subchondral bone of osteotomy
surgery after one year of follow-up compared to the effects of treatment with
an orthopaedic un-loader knee brace.
Study design
In this open-labeled study; patients will be randomized in group (a) treatment
with an orthopaedic un-loader knee brace; or in group (b) a high tibial
osteotomy will be performed. The recruitment period will be maximal 1,5 year
and the total follow up period will be 2 years (with a primary outcome at one
year follow-up).
Intervention
Patients will be randomized in group (a) treatment with an orthopaedic
un-loader knee brace; or in group (b) a high tibial osteotomy.
Study burden and risks
A disadvantage of study participation is that the outpatient clinic visits will
ask additional time of the patient. The patient has to fill in a number of
questionaires. One additional whole leg radiograph will be made (12 months).
Also three DXA scans will be made (start study, and after 12 and 24 months) to
assess the bone mineral density. Finally two MRI of the knee will be made
(start study and after 12 months). Serum and urine will be collected at start
of the study and after 12 months. SPECT CT scan (baseline and after 12 months)
will be performed in patients who give additional informed consent.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
knee pain located over the medial tibiofemoral compartment of the knee, knee pain for more than 3 months, with a severity of the knee pain of 3 on a NRS score or higher (range 0 to 10), radiographic signs of medial knee OA, defined by a Kellgren & Lawrence score of grade 1 or higher, and presence of varus malalignment as measured on a whole leg radiograph.
Exclusion criteria
OA of lateral compartment, rheumatoid arthritis, grade-3 collateral ligament laxity, range of motion of < 100°, a flexion contracture of > 10°, history of fracture or previous open operation of the lower limb, patients that already used a orthopaedic knee brace for knee OA in the same knee, patients with a contralateral high tibial osteotomy will be excluded if the first knee has been included in this trial; thus, if both knees are symptomatic, only the first knee will be included, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45685.078.13 |
| OMON | NL-OMON27146 |