What is the most optimal treatment strategy for children / adolescents with knee complaints? Our hypothesis is (based on the invasive surgical procedure) patients that will be surgical treated (index group) have a clinical relevant gain of pain…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NRS (numeric rating scale) for pain after one year of follow-up
Secondary outcome
amount of pain at the follow-up moments; function score knee; medication use;
adverse events; satisfaction score patient.
Background summary
Treatment of adolescents with non-traumatic knee complaints is a challenge for
an orthopedic surgeon. The initial treatment choice will be non-operatively.
For the non-responders of this traject, an operative treatment is an option.
Which patients will respond to the non-operative traject or not, and what the
most effective treatment is for the the so called non-responders is till date
not clear.
Study objective
What is the most optimal treatment strategy for children / adolescents with
knee complaints? Our hypothesis is (based on the invasive surgical procedure)
patients that will be surgical treated (index group) have a clinical relevant
gain of pain relief after one year compared to the control group (effect size
of minimally 0.5).
Study design
prospective follow-up study with a nested open-label randomized clinical study
Intervention
a) *index treatment* surgical intervention, a deroterening osteotomy of the
femur
b) *control treatment*: painteam; focused on pain medication and TENS.
Study burden and risks
The surgical intervention is one of the treatment options for this target
population in Máxima Medical Center. Patients which will not respond after 1
year of follow-up on the painteam treatment; will have the oppurtunity to
undergo the surgical treatment. The additional burden is that we ask time of
the patient to fill in two questionnaires.
ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
age between 12-17 year; pain in upper leg region, knee and / or lower leg; non-traumatic related complaints; *kneeing in* fenomen; increased internal rotation hip, asymmetric external rotation hip; increased anteversion femur assessed on CT scan; normal mechanical axis; normal MRI.
Exclusion criteria
insufficient command of Dutch language (to fill in questionnaires); not willing to particpate; contra-indications for surgical intervention.
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 | NL54673.015.15 |