The main study objective will be to determine whether a newly developed rehabilitation protocol is non-inferior to the current rehabilitation protocol - golden standard - used after ACL reconstruction.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is our newly developed rehabilitation protocol KROS non-inferior to standard
care.
Definition of inferiority: Unable to reach a functional Limb Symmetry Index of
81%, 9 months after ACLR which corresponds to 90% of standard care.
Secondary outcome
Time to reach a functional limb symmetry index of 80% (end of phase 2)
Time return to play defined as a functional limb symmetry index of 90% (end of
phase 3)
Hamstrings and Quadriceps strength
Quadriceps/Hamstrings ratio
Rate of re-rupture of the ACL graft
Adverse events
Background summary
Return to play after anterior cruciate ligament (ACL) reconstruction is one of
the main goals of surgery. On average it takes up to nine months after surgery
to return to play. A long period of the field could be frustrating for young
athletic individuals. On top of that, reviews have shown that a mere 55 per
cent of patients after ACL reconstruction can return to their pre-injury level
of sports. Also, up to 25% of re-rupture rate has been reported after ACL
reconstruction.
In order to improve these outcomes after ACL reconstruction a new
rehabilitation protocol has been developed. This rehabilitation protocol
focuses on balance, core stability and strength and might be able to speed up
the rehabilitation process, improve the rate of return to pre-injury level of
sport and decrease the amount of re-ruptures after ACL reconstruction. In
addition, the newly developed protocol may be more attractive for participants,
which may lead to better compliance
Study objective
The main study objective will be to determine whether a newly developed
rehabilitation protocol is non-inferior to the current rehabilitation protocol
- golden standard - used after ACL reconstruction.
Study design
non-randomized , controlled, non-inferiority , multicentre trial
Intervention
KROS rehabilitation protocol, see chapter 3.1
Study burden and risks
A structured risk analysis has been carried out. This analysis led to the
conclusion that a negligible risk is accepted.
The KROS rehabilitation protocol replaces the gold standard and is comparable
in intensity, i.e. training twice a week under the supervision of a
physiotherapist. The content of the training will differ. The measuring moments
are carried out during the training sessions, which will take about 15 minutes
extra per measuring moment. In total there are four measuring moments.
Emotional stress is kept to a minimum by on the one hand the non-randomized
nature of the study and on the other hand by the continuous presence of a
physiotherapist during the skating training.
The risk of falls and major balance disturbances is minimized by proper
preparation and setting requirements that a subject must meet before the
skating training starts.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- > 18 years
- ACL deficiency requiring ACL reconstruction
- Intact contralateral knee on physical examination
- written informed consent
Exclusion criteria
- Additional surgical procedures altering postoperative rehabilitation protocol (e.g. meniscal repair)
- Patients with any history of fractures in the lower extremities or spine
- Previous musculoskeletal surgery in the lower extremities
- Neurological conditions leading to musculoskeletal disorders
- Inability to complete Dutch questionnaires
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 | NL66171.042.18 |