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Research comparing acute ACL reconstruction and delayed ACL reconstruction.


- candidate number13793
- NTR NumberNTR3703
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-nov-2012
- Secondary IDs42380 CCMO
- Public TitleResearch comparing acute ACL reconstruction and delayed ACL reconstruction.
- Scientific Title(R)esearch in (A)cute vs (D)elayed (A)CL (R)econstruction.
- ACRONYMRADAR
- hypothesisHypotheis 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.
- Healt Condition(s) or Problem(s) studiedFunctional outcome, ACL reconstruction, ACL rupture, Timing of surgery
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-dec-2013
- Target number of participants150
- InterventionsPatients 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).
- Primary outcomeEarly 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 outcomeAlso, a costs effectiveness analysis associated with the ACL reconstruction and rehabilitation and costs associated ( time off work, fysiotherapeutic costs, etc) will be performed.
- TimepointsMeasurements will be performed preoperatively, and after 6 weeks, 3 and 6 months postoperatively.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Roeland Boer, den
- CONTACT for SCIENTIFIC QUERIES Roeland Boer, den
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryAn 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.
- Main changes (audit trail)
- RECORD13-nov-2012 - 25-nov-2012


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