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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00478894
Other study ID # 070264
Secondary ID 5R01AR053684
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2007
Est. completion date December 2025

Study information

Verified date February 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study we will examine patients who have undergone unilateral ACL reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.


Description:

The purpose of this study is identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery; including patient characteristics (age, gender, body mass index (BMI), activity level, clinical knee alignment), their injuries ("pop" heard at the time of injury, concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g. meniscus and articular cartilage treatments.) Primary outcome measures will be the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and stiffness subscales and joint space width measured on weight-bearing radiographs. Secondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) and Kellgren-Lawrence grading from weight-bearing radiographs.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 432
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 14 Years to 55 Years
Eligibility Inclusion Criteria: - Had primary unilateral ACL reconstruction performed by Dr. Kurt Spindler (Vanderbilt University), Dr. Christopher Kaeding (The Ohio State University), Dr. Rick Parker (Cleveland Clinic), Dr. Jack Andrish (Cleveland Clinic), Dr. Rick Wright (Washington University in St. Louis), or Dr. Matthew Matava (Washington University in St. Louis) - 14-55 years of age at the time of follow-up Exclusion Criteria: - less than 14 years or greater than 55 years - non-active or unable to participate for health reasons

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Vanderbilt University Nashville Tennessee

Sponsors (3)

Lead Sponsor Collaborator
Vanderbilt University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reinke EK, Spindler KP, Lorring D, Jones MH, Schmitz L, Flanigan DC, An AQ, Quiram AR, Preston E, Martin M, Schroeder B, Parker RD, Kaeding CC, Borzi L, Pedroza A, Huston LJ, Harrell FE Jr, Dunn WR. Hop tests correlate with IKDC and KOOS at minimum of 2 y — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Side to side knee joint space difference as seen on x-ray 2-20 years post surgery
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