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Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis.

Publication ,  Journal Article
Lattermann, C; Jacobs, CA; Bunnell, MP; Jochimsen, KN; Abt, JP; Reinke, EK; Gammon, LG; Huebner, JL; Kraus, VB; Spindler, KP
Published in: J Orthop Res
March 2017

Anterior cruciate ligament (ACL) injuries are common and lead to posttraumatic osteoarthritis (PTOA) in a high percentage of patients. Research has been ineffective in identifying successful treatment options for people suffering from symptomatic PTOA resulting in a shift of focus toward the young, ACL injured patients at risk of developing PTOA. Randomized clinical trials examining the very early phase after ACL injury are ideal to study this population; however, these trials face significant challenges regarding recruitment as well as reproducibility of patient-reported outcomes (PROs) and inflammatory and/or chondrodegenerative biomarkers associated with early PTOA. The aim of this work was to develop an approach to allow for early recruitment into an RCT for early treatment following ACL injury and to analyze the variability of commonly used measures and biomarkers at various time points after injury. This paper reports the study design and data related to the first month of treatment for the placebo group of an ongoing 2-year clinical trial to evaluate the effect of an early intra-articular intervention after ACL injury. The results of this study suggest that acute ACL injury results in early changes of both inflammatory and chondrodegenerative biomarkers. These results also provide vital information for researchers to consider when developing future protocols, both related to the logistics of early patient enrollment as well as the appropriate timing of biomarker and patient-reported outcome collection. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:641-650, 2017.

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Published In

J Orthop Res

DOI

EISSN

1554-527X

Publication Date

March 2017

Volume

35

Issue

3

Start / End Page

641 / 650

Location

United States

Related Subject Headings

  • Research Design
  • Patient Reported Outcome Measures
  • Osteoarthritis, Knee
  • Orthopedics
  • Humans
  • Clinical Protocols
  • Biomarkers
  • Anterior Cruciate Ligament Injuries
  • 4207 Sports science and exercise
  • 4003 Biomedical engineering
 

Citation

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Lattermann, C., Jacobs, C. A., Bunnell, M. P., Jochimsen, K. N., Abt, J. P., Reinke, E. K., … Spindler, K. P. (2017). Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res, 35(3), 641–650. https://doi.org/10.1002/jor.23329
Lattermann, Christian, Cale A. Jacobs, Mary Proffitt Bunnell, Kate N. Jochimsen, John P. Abt, Emily K. Reinke, Lee G. Gammon, Janet L. Huebner, Virginia B. Kraus, and Kurt P. Spindler. “Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis.J Orthop Res 35, no. 3 (March 2017): 641–50. https://doi.org/10.1002/jor.23329.
Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, et al. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641–50.
Lattermann, Christian, et al. “Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis.J Orthop Res, vol. 35, no. 3, Mar. 2017, pp. 641–50. Pubmed, doi:10.1002/jor.23329.
Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641–650.
Journal cover image

Published In

J Orthop Res

DOI

EISSN

1554-527X

Publication Date

March 2017

Volume

35

Issue

3

Start / End Page

641 / 650

Location

United States

Related Subject Headings

  • Research Design
  • Patient Reported Outcome Measures
  • Osteoarthritis, Knee
  • Orthopedics
  • Humans
  • Clinical Protocols
  • Biomarkers
  • Anterior Cruciate Ligament Injuries
  • 4207 Sports science and exercise
  • 4003 Biomedical engineering