Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up

Osteoarthritis Clinical Trial

— MOON-Onsite  

Official title:

Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00478894
• Other study ID #: 070264
• Secondary ID: 5R01AR053684
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Rupture
• Rupture of Anterior Cruciate Ligament

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