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Training programs to reduce ACL injuries would benefit from higher level evidence to demonstrate effectiveness
Investigator notes that injury-prevention studies are difficult to conduct, time-consuming and expensive.
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PROVIDENCE, R.I. — A review of the current orthopedic literature has revealed a lack of evidence-based proof of the effectiveness of athletic training programs to reduce the risk of ACL injuries, according to an investigator from Boise, Idaho.
“Do training programs reduce knee injury or ACL injury? The results are equivocal,” said Kevin G. Shea, MD. “Does this mean that injury programs do not work? That is an emphatic no. The trend suggests a treatment effect in some, but not all, studies and the level of evidence in this field is not the highest due to study bias. Questions about treatment efficacy still exist.”
Shea’s comments came during the 2010 Annual Meeting of the American Orthopaedic Society for Sports Medicine, here.
No level I data
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Image: Beadling L, Orthopedics Today |
Shea and colleagues’ study consisted of a review of the literature for ACL and knee injury prevention trials. They searched three major databases — Medline, Cochrane, CINAHL — for ACL and knee injury as outcome measures in these studies rated as level I, II, or III based on the Journal of Bone and Joint Surgery (JBJS) classification for study design.
“We identified 15 articles that met this criteria using the JBJS levels of ranking. We had no level I trials, 12 level II trials and three level III trial designs,” Shea said.
In terms of the levels of evidence and the outcomes measures, for the level II trials 10 of 12 addressed ACL injuries and 12 of 12 addressed knee injury. For the level III trials, two of three looked at ACL and three of three looked at knee injuries.
In terms of the results for the reduction in knee injuries, seven of 12 of the level II trials showed a statistically significant reduction in knee injury. For the level III trials, two of three showed a reduction in knee injury. “When we looked at outcomes for ACL injury, for the level II designs, four of 10 showed a reduction of ACL injury and of the level II trials, one of two showed a significant reduction in ACL injury,” Shea reported.
The investigators found that in terms of design elements that led to bias in the studies, there were several bias elements including follow-up of less than 80% in some of these studies, intention to treat analysis was used by four of eight randomized trials, concealment of allocation was not clearly reported in all of the randomized trials and blinding of the outcomes assessors was not clear in most of the trials.
Difficult trials
Shea acknowledged that injury-prevention studies are difficult to conduct, they are time consuming, and expensive. “It may be impossible to conduct the perfect study in this area, that removes all possible bias. But study designs with less bias will provide better evidence about treatment efficacy,” he said.
Studies performed during the past 10 years, have shown an improvement in study designs including less bias and more level II trials. “However, there is a significant reduction of knee injury in seven of those 12 trials and a significant reduction of ACL injuries in four of the 10 trials. Clearly more research is necessary about program effectiveness.”
He noted that there is a significant amount of trial heterogeneity, with the different investigations using varying techniques, muscle training, gender focus, study duration, frequency of treatment and timing of the programs.
“The heterogeneity of these studies truly restricts the ability to do a meta-analysis,” he said.
In future investigations, Shea said orthopedic researchers need to continue to look at the ACL injury as a neuromuscular disorder in the gait lab and to determine the critical training elements for injury prevention.
“We need to confirm the effectiveness of interventional programs and use trials designed with less bias and to look at factors that may increase the risk of injury including subgroup analysis that suggest that some groups may respond better than others,” he said. – by Lee Beadling
Reference:
- Shea KG, Grimm NL, Jacobs JC, Simonson S. ACL and knee injury prevention programs for young athletes: Do they work? Presented at the 2010 Annual Meeting of the American Orthopaedic Society for Sports Medicine. July 15-18. Providence, R.I.
- Kevin G. Shea, MD, can be reached at kshea@intermountainortho.com.
When you look at the risk factor ratio when you conduct a randomized trial, you look at what the benefit is compared to the cost of doing the trial. So, the prevention studies above shows an intervention that causes no harm during training at very little money and you don’t have the perfect level I literature, but a reasonable pool of literature that suggests a possible benefit. Any further study design at level 1 does not require you to randomize the patients, but use a cluster design which means that you have to randomize by teams, which is probably the most complicated statistical modeling that you’d ever have to do. So given the present data, what benefit is there in trying to conduct another trial?
– Kurt P. Spindler, MD
Professor and
Vice-Chairman, Department of Orthopaedics and Rehabilitation
Vanderbilt
University Medical School
Nashville, Tenn.
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