To investigate the (cost) effectiveness of early ACL reconstruction ( 3 months after injury). Hypotheis is that early ACL reconstruction results in less loss of function and muscle strength of the knee and in an faster return to the pre-injury level…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hypothesis: An early ACL-reconstruction will give a shorter period of time-off
sports. This will be measured with objective measurements, like various hop
tests and proprioception and coordination tests. To investigate whether an
early ACL-reconstruction results in a faster functional recovery and a higher
level of physical functioning, compared to the usual timing (>3 months after
ACL rupture)
Secondary outcome
Secondary study parameters: The costs associated with the ACL reconstruction
and rehabilitation and costs associated ( time off work, fysiotherapeutic
costs, etc) are investigated. The expectation is that they will be lower.
Background summary
An anterior cruciate ligament (ACL) rupture is a common injury of the knee in
sports with many pivoting movements such as football, handball, volleyball and
basketball. In case of instability of the knee and the desire of the patient to
return to his / her pre-injury level of sports, a surgical reconstruction of
the ACL is recommended. Current guidelines recommend first 3 months of
physiotherapy before an ACL reconstruction is performed. However, because of
improvements in arthroscopy and physiotherapy, it is possible to perform an ACL
reconstruction within the first weeks following the injury. Potential added
value of early ACL reconstruction may be that a patient has less loss of
function of the knee and may also return earlier to his / her pre-injury level
of activity. Secondary, it is expected that early ACL reconstruction will
result in a significant cost reduction because physical therapy prior to ACL
reconstruction is shortened and it is expected that the postoperative treatment
process also will be shorter. The little scientific research that has been done
on this subject, confirm that an earlier timing of ACL reconstruction results
in comparable or better outcome, compared to the ususal timing. However, the
evidence is scarce and no RCT has been conducted on this subject.
Study objective
To investigate the (cost) effectiveness of early ACL reconstruction (<6 weeks
after injury), compared to the usual timing of ACL reconstruction (> 3 months
after injury). Hypotheis is that early ACL reconstruction results in less loss
of function and muscle strength of the knee and in an faster return to the
pre-injury level of activity.
Study design
A prospective randomized multicenter study. Timing of ACL reconstruction
(within 6 weeks or after three months following injury) will be randomly
determined. Patients are enrolled in 12 participating clinics.
Intervention
Early ACL-reconstruction (< 6 weeks) vs delayed ACL-reconstruction (> 3 months)
Study burden and risks
Results of this study will contribute to the optimization of the treatment of
patients with an ACL injury. It is expected that the risks associated with
participation in the study are negligible. The research involves only a change
in timing of surgery (ACL reconstruction) that has proven to be effective and
safe. A possible risk to participation in the study is the risk of
artrofibrosis at an early ACL reconstruction. However, since a preoperative
extension and flexion limitation is an exclusion criteria, it is expected that
the probability of the occurrence of artrofibrosis in the group receiving early
ACL reconstruction will undergo will be just as large as in the group operated
at 3 months after injury. The risks associated with the measurements made in
this study are negligible, since the measurements are similar to physical
exercises and workouts that patients after ACL reconstruction perform during
physiotherapy as part of their rehabilitation.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Active young (18 - 40) pivoting sportsmen/women or heavy duty workers, Tegner score > 5
- Isolated ACl injury
- Ambition to return to pre-injury level
- Fresh ACL rupture < 4 weeks
- Diagnosis of ACL-rupture by physical examination (Lachmann, pivot-shift) and/or MRI
Exclusion criteria
- Re-injury ACL ipsilateral
- Additional contra- or ipsilateral injury, for example a fracture
- Multiple ligamentous injury (MCL-lesion, PCL-rupture, knee luxation, posterolateral instability)
- Previous traumasurgery lower extremity, for example pelvic, hip, knee or ankle
- Osteoartritis grade IV injured knee
- Accompanying neurovascular injury
- Loss of Extension > 10 degrees and/or Loss of Flexion > 20 degrees, not induced by a mechanical cause (meniscus interposition, cyclops). This can be diagnosed by MRI or arthroscopy.
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 |
---|---|
Other | 13793 |
CCMO | NL42380.042.12 |