Rupture of Anterior Cruciate LigamentMOON-OnsiteNCT00478894
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up
An observational study of Rupture of Anterior Cruciate Ligament and Osteoarthritis, run by Vanderbilt University at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament, Osteoarthritis
- How many people
- 432 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2007to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of three surgeons and meeting eligibility criteria
Who may be able to join
- 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
Who cannot join
- less than 14 years or greater than 55 years
- non-active or unable to participate for health reasons
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43221
Vanderbilt University
Nashville, Tennessee, 37232
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up
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.
Read the detailed 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.
- Keywords
- Anterior cruciate ligament / injuries, Anterior cruciate ligament / surgery, knee injuries / surgery, outcomes research, prospective studies, osteoarthritis
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Side to side knee joint space difference as seen on x-ray
Measured: 2-20 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2025
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kurt P. Spindler, Vanderbilt University
- Investigators
- Kurt P Spindler, M.D., Principal investigator, Cleveland Clinic / Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478894
- Sponsor's protocol ID
- 070264
- Other IDs
- 5R01AR053684
- Acronym
- MOON-Onsite
- Status last verified
- Jan 2026
- First submitted
- 24 May 2007
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 years after primary ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1806-16. doi: 10.1007/s00167-011-1473-5. Epub 2011 Mar 29.
PubMed 21445595Ramkumar PN, Tariq MB; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Huston LJ, Jones MH, Kaeding CC, Kattan MW, Marx RG, Matava MJ, McCarty EC, Parker RD, Vidal AF, Wolcott ML, Wolf BR, Wright RW, Spindler KP. Risk Factors for Loss to Follow-up in 3202 Patients at 2 Years After Anterior Cruciate Ligament Reconstruction: Implications for Identifying Health Disparities in the MOON Prospective Cohort Study. Am J Sports Med. 2019 Nov;47(13):3173-3180. doi: 10.1177/0363546519876925. Epub 2019 Oct 7.
PubMed 31589465Jacobs CA, Peabody MR, Lattermann C, Vega JF, Huston LJ, Spindler KP; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Jones MH, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Parker RD, Reinke EK, Wolcott ML, Wolf BR, Wright RW, Vidal AF. Development of the KOOSglobal Platform to Measure Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Oct;46(12):2915-2921. doi: 10.1177/0363546518789619. Epub 2018 Aug 3.
PubMed 30074823
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up
- ClinicalTrials.gov ID
- NCT00478894
- Acronym / sponsor ID
- MOON-Onsite / 070264
- Keywords
- Anterior cruciate ligament / injuries, Anterior cruciate ligament / surgery, knee injuries / surgery, outcomes research, prospective studies, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2007
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of three surgeons and meeting eligibility criteria
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- less than 14 years or greater than 55 years
- non-active or unable to participate for health reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Side to side knee joint space difference as seen on x-ray
Time frame: 2-20 years post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 21445595Reinke 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 years after primary ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1806-16. doi: 10.1007/s00167-011-1473-5. Epub 2011 Mar 29.
- Derived from this study: PubMed 31589465Ramkumar PN, Tariq MB; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Huston LJ, Jones MH, Kaeding CC, Kattan MW, Marx RG, Matava MJ, McCarty EC, Parker RD, Vidal AF, Wolcott ML, Wolf BR, Wright RW, Spindler KP. Risk Factors for Loss to Follow-up in 3202 Patients at 2 Years After Anterior Cruciate Ligament Reconstruction: Implications for Identifying Health Disparities in the MOON Prospective Cohort Study. Am J Sports Med. 2019 Nov;47(13):3173-3180. doi: 10.1177/0363546519876925. Epub 2019 Oct 7.
- Derived from this study: PubMed 30074823Jacobs CA, Peabody MR, Lattermann C, Vega JF, Huston LJ, Spindler KP; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Jones MH, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Parker RD, Reinke EK, Wolcott ML, Wolf BR, Wright RW, Vidal AF. Development of the KOOSglobal Platform to Measure Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Oct;46(12):2915-2921. doi: 10.1177/0363546518789619. Epub 2018 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt P Spindler, M.D. principal investigator
Cleveland Clinic / Vanderbilt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture of Anterior Cruciate Ligament and Osteoarthritis, run by Vanderbilt University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side to side knee joint space difference as seen on x-ray (time frame: 2-20 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478894, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.