No registrations found.
ID
Source
Brief title
Health condition
timing of surgery
ACL rupture
ACL reconstruction
functional outcome
Sponsors and support
Dr. K. W. Wendt
Intervention
Outcome measures
Primary outcome
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, which will be objectively measured with a sequence of hoptests.
Secondary outcome
Also, a costs effectiveness analysis associated with the ACL reconstruction and rehabilitation and costs associated ( time off work, fysiotherapeutic costs, etc) will be performed.
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
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
Measurements will be performed preoperatively, and after 6 weeks, 3 and 6 months postoperatively.
Intervention
Patients will be randomised in:
1. Early ACL reconstruction (<6 weeks after injury);
2. Delayed surgery, which is the usual timing of ACL reconstruction (> 3 months after injury).
Inclusion criteria
1. Active, pivoting sport player;
2. Age between 18 and 40;
3. Desire to return to pre-injury level;
4. Fresh ACL rupture (< 4 weeks);
5. Diagnosis with positive Lachmann/pivotshift and/or MRI.
Exclusion criteria
1. Re-injury ACL;
2. Concommitant lesion same/other site (for example a fracture);
3. Multiple ligamentous injury;
4. Chondropathy grade IV;
5. A persisting loss of extension of 10 degrees and flexion deficit of 20 degrees, not of cyclops or bucket-handle origin.
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 |
|---|---|
| NTR-new | NL3553 |
| NTR-old | NTR3703 |
| Other | CCMO : 42380 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |