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. 2012 Nov;40(11):2648-52.
doi: 10.1177/0363546512465409.

The feasibility of randomized controlled trials for early arthritis therapies (Earth) involving acute anterior cruciate ligament tear cohorts

Constance R Chu  1 , Bruce D Beynnon, Jason L Dragoo, Glenn S Fleisig, Joseph M Hart, Michael Khazzam, Kevin M Marberry, Bradley J Nelson; EARTH Group
Affiliations

The feasibility of randomized controlled trials for early arthritis therapies (Earth) involving acute anterior cruciate ligament tear cohorts

Constance R Chu et al. Am J Sports Med. 2012 Nov.

Abstract

Osteoarthritis (OA) is a leading cause of disability for which disease-modifying treatments are lacking. Anterior cruciate ligament (ACL) tear provides opportunities to study potential interventions from the initiation of heightened OA risk at the time of injury. This institutional review board (IRB)-approved prospective cross-sectional study (level of evidence: 2) was performed to test the hypothesis that adequate sample sizes of ACL-injured subjects to support randomized controlled trials (RCT) of early intervention strategies can be achieved. A total of 307 ACL-injured patients were entered into the database from 3-month collection periods at 7 clinical sites, with 65 subjects aged 18 to 30 years passing the inclusion/exclusion criteria. From sites that were IRB approved to ask, 89 of 96 (93%) subjects were willing to participate in an RCT. Extrapolating the 3-month data to a 1-year recruitment period would potentially yield 242 subjects aged 18 to 30 years willing to undergo randomization. This study shows that adequate sample sizes to perform RCT of early intervention strategies in ACL-injured cohorts comprising healthy young adults ages 18 to and 30 without prior joint injuries can be achieved within 1 to 2 years through recruitment at 5 to 7 orthopaedic sports medicine practices. Continued development of ACL-tear cohorts will provide the clinical base to critically evaluate new diagnostic and therapeutic strategies that can help transform clinical care of OA from palliation to prevention.

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Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: Funding sources include the AOSSM, NIH R01 AR 052784 (CRC), the Albert Ferguson Endowed Chair (CRC) University of Pittsburgh, and the Orthopedic Departments and Sports Medicine Practices at the American Sports Medicine Institute–Alabama, A.T. Still University–Missouri, Stanford University, University of Minnesota/TRIA, University of Texas Southwestern, the University of Vermont, and the University of Virginia.

Figures

Figure 1
Figure 1
Sex and age: (A) Overall, 53% of eligible subjects were male and 47% were female. (B) Females, however, composed 72% of the ACL injuries among teenagers ages 14 to 17 years entered into the database. The percentage of males exceeded that of females in age groups 18 years and older.
Figure 2
Figure 2
Time from injury to orthopaedic evaluation: The majority of eligible subjects were evaluated by an orthopaedic surgeon within 1 month of injury, with 23% seen within 48 hours, 49% seen within 1 week, and 75% seen within 1 month.
See this image and copyright information in PMC

References

    1. Chu CR, Beynnon BD, Buckwalter JA, et al. Closing the gap between bench and bedside research for early arthritis therapies (EARTH): report from the AOSSM/NIH U-13 Post–Joint Injury Osteoarthritis Conference II. Am J Sports Med. 2011;39:1569–1578. - PMC - PubMed
    1. Chu CR, Williams AA, Coyle CH, Bowers ME. Early diagnosis to enable early treatment of pre-osteoarthritis. Arthritis Res Ther. 2012;14:212. - PMC - PubMed
    1. Csintalan RP, Inacio MC, Funahashi TT. Incidence rate of anterior cruciate ligament reconstructions. Perm J. 2008;12:17–21. - PMC - PubMed
    1. Daniel DM, Stone ML, Dobson BE, Fithian DC, Rossman DJ, Kaufman KR. Fate of the ACL-injured patient. A prospective outcome study. Am J Sports Med. 1994;22:632–644. - PubMed
    1. Frobell RB, Lohmander LS, Roos EM. The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment. Contemp Clin Trials. 2007;28:295–302. - PubMed

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