Functional treatment with a brace and early physiotherapy will result in improved Kujala scores (reflecting better functional outcome with less pain) and SF-36 scores (reflecting higher quality of life) at 1 year compared with plaster immobilization…
ID
Source
Brief title
Condition
- Muscle disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Functional outcome and pain, as measured by the Kujala score, one year after
brace and plaster treatment in patients over 12 years of age, who sustained an
acute traumatic patella luxation.
- Quality of life, as measured by the SF-36 score, one year after brace and
plaster treatment.
Secondary outcome
- Kujala scores (reflecting functional outcome and pain) at three, six weeks
and three, six and twelve months.
- SF-36 scores (reflecting quality of life) at three, six weeks and three, six
and twelve months.
- The effect of a brace or plaster treatment on the level of pain experienced
by the patients (VAS) at three, six weeks and three, six and twelve months.
- The range of motion (extension, flexion) of the knee joint at six weeks and
three, six and twelve months. The range of motion will be measured by the
research coordinator or research assistant with a goniometer.
- To examine the effect of a brace versus plaster treatment on reluxation rate
at three, six weeks and three, six and twelve months.
- Complications as venous thrombosis and neurological deficit.
Background summary
Acute patellar dislocations are relatively common. The incidence of primary
patellar dislocation is 5.8 per 100,000, and this increases to twenty-nine per
100,000 in the ten to seventeen-year-old age group.
Acute patellar dislocations may result in patellar instability, pain, recurrent
dislocations, decreased level of sporting activity and patellofemoral arthritis.
Occasionally, spontaneous reduction occurs, but if not, closed reduction can
easily be performed at the emergency ward. Following reposition of the patella,
different treatment modalities are described like plaster immobilisation,
surgical treatment of ruptured ligaments or functional treatment.
According to recent literature, non-operative treatment is recommended for
primary patellar dislocations. However, no well-designed studies assessing the
most appropriate form and/or length of initial mobilization have been
published.
In a systematic review by Stefancin it is stated that patients should be
briefly immobilized (2-3 weeks).5 Colvin et al recommend non-operative
treatment with patellar bracing.
In most hospitals in the Netherlands patients with acute patellar dislocation
are treated with plaster/brace immobilization during 6 weeks.
However, following 6 weeks immobilization of the knee patients will have
significant atrophy of the quadriceps muscles. The vastus medialis obliquus is
the first part of the quadriceps to weaken and the last to strengthen when
function is inhibited. It is recognized that atrophy of the vastus medialis is
correlated with lateral instability. Therefore, our hypothesis is that
prevention of vastus medialis atrophy is associated with a positive effect on
knee function and re-luxation rate.
Study objective
Functional treatment with a brace and early physiotherapy will result in
improved Kujala scores (reflecting better functional outcome with less pain)
and SF-36 scores (reflecting higher quality of life) at 1 year compared with
plaster immobilization following primary patella luxation.
Functional treatment with a brace results in a similar reluxation rate at 1
year compared with plaster treatment.
Study design
Randomized controlled multicentre trial: all patients =/> 12 years with a
first-time traumatic patella luxation are included. In all patients the patella
luxation will be reduced. Patients with a complex luxation (combined with a
fracture) are excluded. The strategy involves plaster for one week in both
groups followed by a stabilizing brace for 2 weeks, combined with a well
defined physiotherapy protocol for the first group and (regular) plaster
treatment during 5 more weeks for the second group of patients. Clinical
function, pain and reluxation rate will be monitored at regular intervals over
the subsequent 12 months (1 week (pain), 3 weeks, 6 weeks, 3 months, 6 months
and 12 months).
Intervention
The first group will be treated with plaster during 6 weeks.
The other group (intervention group) will be treated plaster during 1 week,
followed by a stabilizing brace for 2 weeks and physiotherapie (After one
week).
Study burden and risks
There are no risks associated with participation. Both treatment modalities are
non-invasive. The only disadvantage for the participants is the time consumed
by filling-in the questionnaires.
Reinier de Graafweg 3-11
2625 AD Delft
Nederland
Reinier de Graafweg 3-11
2625 AD Delft
Nederland
Listed location countries
Age
Inclusion criteria
1. Men or women aged 12 years and older (with no upper age limit)
2. A simple (without fracture) primary luxation of the patella
3. Provision of informed consent by patient and/or parents
Exclusion criteria
1. Patients =/< 11 years of age.
2. Patients with a complex (with fracture) luxation
3. Patients with pathological, recurrent or open luxations.
4. Patients with a complex knee function (i.e., stiff or painful knee, anatomic variation (valgus/varus) or neurological disorder of the lower limb) prior to the injury.
5. Retained hardware around the affected knee.
6. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy, osteomalacia).
7. Patients with a connective tissue disease or (joint) hyper flexibility disorder, such as Marfan, Ehler Danlos and other related disorders
8. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded).
9. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgment of the attending physician.
10. Patient with multiple injuries.
11. High Energetic Trauma patients
12. Comatose patients.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL26998.098.09 |