Rupture of Anterior Cruciate LigamentMARSNCT00625885
Multicenter ACL Revision Study (MARS)
An observational study of Rupture of Anterior Cruciate Ligament, run by Vanderbilt University Medical Center at 49 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effects of modifiable risk factors on patient-reported quality of life, physical activity levels, and risk of early osteoarthritis following revision anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- How many people
- 1,234 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 26 Mar 2006to 31 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All ACL-deficient candidates scheduled for a revision ACL reconstruction at one of the participating MARS sites.
Who may be able to join
- All ACL-deficient candidates presenting to the clinic, between the ages of 12† and 65, scheduled to have a revision ACL reconstruction by a participating (MARS Study) surgeon.
- All participants must have undergone a primary ACL reconstruction in the past and are currently identified as having experienced failure of their primary ACL reconstruction, as defined by either MRI, knee laxity (KT > 5mm), a positive pivot shift or Lachman's, functional instability, and/or by arthroscopic confirmation.
- All ACL-deficient patients seeking a revision ACL reconstruction that have either partial (Grade I or II) and/or complete (Grade III) simultaneous ligamentous injuries to the collateral ligaments (MCL or LCL) and/or the posterior cruciate ligament (PCL) will also be included.
- Non-operative treatment of patients with ACLR failure are also eligible to participate.
- The following graft types will be the only ones accepted for inclusion:
- any autograft
Show all 10Show fewer
- Fresh-frozen allografts from a single donor source (Musculoskeletal Transplant Foundation (MTF); Edison, NJ). These grafts should consist of either:
- bone-patellar tendon-bone
- tibialis anterior/posterior
- achilles tendon
Who cannot join
- Patients presenting with prior infection, arthrofibrosis, or regional pain syndrome.
- Subjects will be excluded if their allograft source does not come from MTF.
- Patients unwilling or unable to complete their repeat questionnaire two years after their initial visit.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States47 sites
University of Michigan
Ann Arbor, Michigan, 48106
Orthopaedic Associates of Aspen and Glenwood
Aspen, Colorado, 81611
Intermountain Orthopaedics
Boise, Idaho, 83703
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Colorado
Boulder, Colorado, 80304
Bridger Orthopaedic and Sports Medicine
Bozeman, Montana, 59715
University of Buffalo
Buffalo, New York, 14214
University of Vermont College of Medicine
Burlington, Vermont, 05405
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Perry Orthopaedics and Sports Med (Carolinas Healthcare System)
Charlotte, North Carolina, 28211
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43221
UHZ Sports Medicine Institute
Coral Gables, Florida, 33146
W.B. Carroll Memorial Clinic
Dallas, Texas, 75204
Duke University
Durham, North Carolina, 27710
Slocum Research and Education Foundation
Eugene, Oregon, 97401
Connecticut Children's Medical Center
Farmington, Connecticut, 06032
University of Connecticut Health Center
Farmington, Connecticut, 06034
Cheaspeake Orthopaedics and Sports Medicine Center
Glen Burnie, Maryland, 21061
New Hamphsire Knee Center
Holderness, New Hampshire, 03217
Methodist Sports Medicine Center
Indianapolis, Indiana, 46280
University of Iowa
Iowa City, Iowa, 52242
Southeastern Orthopaedics / Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37909
Scripps Memorial Hospital (OrthoCal Healthcare)
La Jolla, California, 92123
National Sports Medicine Institute
Lansdowne Town Center, Virginia, 20176
University of California - Los Angeles (UCLA)
Los Angeles, California, 90095
Vanderbilt University
Nashville, Tennessee, 37232
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
NYU School of Medicine
New York, New York, 10016
Hospital for Special Surgery
New York, New York, 10021
Manhattan Orthopaedics, P.C.
New York, New York, 10021
The Rothman Institute / Thomas Jefferson University
Philadelphia, Pennsylvania, 19085
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Booth, Bartolozzi, Balderston Orthopaedics
Philadelphia, Pennsylvania, 19107
Orthopaedic and Fracture Clinic
Portland, Oregon, 97225
Princeton Orthopaedic Associates
Princeton, New Jersey, 08540
Inland Orthopaedics/Washington State University
Pullman, Washington, 99163
Town Center Orthopaedic Associates
Reston, Virginia, 20190
Mayo Clinic
Rochester, Minnesota, 55905
Regions Hospital (Health Partners Research Foundation)
Saint Paul, Minnesota, 55101
San Antonio Orthopaedic Group
San Antonio, Texas, 78216
University of California - San Francisco
San Francisco, California, 94143
Orthopaedic Institute
Sioux Falls, South Dakota, 57115
Washington University at St. Louis
St Louis, Missouri, 63141
Commonwealth Orthopaedics and Rehabilitation
Vienna, Virginia, 22181
Keller Army Community Hospital - USMA
West Point, New York, 10996
Canada2 sites
Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario
London, Ontario
Royal Columbian Hospital (FraserHealth)
New Westminster, British Columbia, V3L3W7
About this study
The purpose of this study is to determine the effects of modifiable risk factors on patient-reported quality of life, physical activity levels, and risk of early osteoarthritis following revision anterior cruciate ligament (ACL) reconstruction.
The investigators hypothesize that modifiable variables exist at the time of revision ACL reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.
Read the detailed description
Injury to the anterior cruciate ligament (ACL) results in a threat to an active lifestyle and exposes the patient to risk of osteoarthritis. ACL reconstruction is typically chosen by individuals to allow a return to their previous work and sports activities. The results of primary ACL reconstruction have in general been good at restoring functional stability. Primary ACL reconstruction has a graft failure rate ranging from approximately 2%-8%. Consensus amongst surgeons and low-level evidence (retrospective case series) indicate a worse outcome following revision ACL reconstruction compared to primary reconstruction. The typical surgeon performs less than 10 revision ACL reconstructions per year. Thus, the ability of any single surgeon or small group of surgeons to accumulate enough cases to effectively analyze predictors for worse outcome is impossible.
With this in mind, the Multi-Center ACL Revision Study (MARS) group was established as a multi-center surgeon group to perform a prospective longitudinal cohort analysis of revision ACL reconstruction. This is a mixed group of academic and private practice physicians and has been supported and endorsed by the American Orthopedic Society for Sports Medicine (AOSSM).
This study focuses on the predictors for ACL revision outcome at 2, 6,10 and 20 years following a patient's revision ACL reconstruction. This will be accomplished by three Specific Aims. Specific Aim 1 will determine the independent predictors of patient-reported quality of life, utilizing a general (SF-36) and knee-specific (Knee Injury and Osteoarthritis Outcome Score - KOOS) validated outcome instrument. Specific Aim 2 will determine the independent predictors of sports function utilizing three validated outcome instruments (the Marx activity level, International Knee Documentation Committee Subjective form - IKDC, and the KOOS sports and recreation subscale). Specific Aim 3 will identify those independent modifiable predictors measured at the time of the revision ACL reconstruction associated with symptoms of knee osteoarthritis at up to 20 years post-surgery. Symptoms will be quantified using the validated survey instrument the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Once the predictors for these worse outcomes are identified, surgeons can be educated in potential modifiable variables to improve the outcome.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior Cruciate Ligament/injuries, Anterior Cruciate Ligament/surgery, Knee injuries/surgery, Outcomes research, Prospective Studies
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft re-rupture
Measured: 2, 6, 10, and 20 years after revision ACL surgery
Secondary outcomes (1)
Patient based outcome measures
Activity level (as measured by the Marx activity scale). Sports function (as measured by the KOOS and IKDC). Pain and swelling (as measured by the WOMAC).
Measured: 2, 6,10, and 20 years after revision ACL surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start26 Mar 2006
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kurt P. Spindler, Vanderbilt University
- Investigators
- Rick W. Wright, M.D., Principal investigator, Vanderbilt University Medical CenterKurt P. Spindler, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625885
- Sponsor's protocol ID
- 070110
- Other IDs
- R01AR060846
- Acronym
- MARS
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2008
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
MARS Group; Vasavada K, Vasavada V, Moran J, Devana S, Lee C, Hame SL, Jazrawi LM, Sherman OH, Huston LJ, Haas AK, Allen CR, Cooper DE, DeBerardino TM, Spindler KP, Stuart MJ, Ned Amendola A, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, David TS, Dunn WR, Flanigan DC, Frederick RW, Ganley TJ, Gatt CJ Jr, Gecha SR, Giffin JR, Hannafin JA, Lindsay Harris N Jr, Hechtman KS, Hershman EB, Hoellrich RG, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, Wright RW, York JJ. A Novel Machine Learning Model to Predict Revision ACL Reconstruction Failure in the MARS Cohort. Orthop J Sports Med. 2024 Nov 14;12(11):23259671241291920. doi: 10.1177/23259671241291920. eCollection 2024 Nov.
PubMed 39555321MARS Group; Cooper DE, Dunn WR, Huston LJ, Haas AK, Spindler KP, Allen CR, Anderson AF, DeBerardino TM, Lantz BBA, Mann B, Stuart MJ, Albright JP, Amendola AN, Andrish JT, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Bechler JR, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Campbell JD, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, Dahm DL, David TS, Flanigan DC, Frederick RW, Ganley TJ, Garofoli EA, Gatt CJ Jr, Gecha SR, Giffin JR, Hame SL, Hannafin JA, Harner CD, Harris NL Jr, Hechtman KS, Hershman EB, Hoellrich RG, Hosea TM, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Sherman OH, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, York JJ, Wright RW. Physiologic Preoperative Knee Hyperextension Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report From the MARS Group. Am J Sports Med. 2018 Oct;46(12):2836-2841. doi: 10.1177/0363546518777732. Epub 2018 Jun 8.
PubMed 29882693MARS Group. Meniscal and Articular Cartilage Predictors of Clinical Outcome After Revision Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Jul;44(7):1671-9. doi: 10.1177/0363546516644218. Epub 2016 May 9.
PubMed 27161867
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter ACL Revision Study (MARS)
- ClinicalTrials.gov ID
- NCT00625885
- Acronym / sponsor ID
- MARS / 070110
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior Cruciate Ligament/injuries, Anterior Cruciate Ligament/surgery, Knee injuries/surgery, Outcomes research, Prospective Studies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 26 Mar 2006 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 28 Feb 2008 (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.
The purpose of this study is to determine the effects of modifiable risk factors on patient-reported quality of life, physical activity levels, and risk of early osteoarthritis following revision anterior cruciate ligament (ACL) reconstruction.
The investigators hypothesize that modifiable variables exist at the time of revision ACL reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.
Detailed description
Injury to the anterior cruciate ligament (ACL) results in a threat to an active lifestyle and exposes the patient to risk of osteoarthritis. ACL reconstruction is typically chosen by individuals to allow a return to their previous work and sports activities. The results of primary ACL reconstruction have in general been good at restoring functional stability. Primary ACL reconstruction has a graft failure rate ranging from approximately 2%-8%. Consensus amongst surgeons and low-level evidence (retrospective case series) indicate a worse outcome following revision ACL reconstruction compared to primary reconstruction. The typical surgeon performs less than 10 revision ACL reconstructions per year. Thus, the ability of any single surgeon or small group of surgeons to accumulate enough cases to effectively analyze predictors for worse outcome is impossible.
With this in mind, the Multi-Center ACL Revision Study (MARS) group was established as a multi-center surgeon group to perform a prospective longitudinal cohort analysis of revision ACL reconstruction. This is a mixed group of academic and private practice physicians and has been supported and endorsed by the American Orthopedic Society for Sports Medicine (AOSSM).
This study focuses on the predictors for ACL revision outcome at 2, 6,10 and 20 years following a patient's revision ACL reconstruction. This will be accomplished by three Specific Aims. Specific Aim 1 will determine the independent predictors of patient-reported quality of life, utilizing a general (SF-36) and knee-specific (Knee Injury and Osteoarthritis Outcome Score - KOOS) validated outcome instrument. Specific Aim 2 will determine the independent predictors of sports function utilizing three validated outcome instruments (the Marx activity level, International Knee Documentation Committee Subjective form - IKDC, and the KOOS sports and recreation subscale). Specific Aim 3 will identify those independent modifiable predictors measured at the time of the revision ACL reconstruction associated with symptoms of knee osteoarthritis at up to 20 years post-surgery. Symptoms will be quantified using the validated survey instrument the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Once the predictors for these worse outcomes are identified, surgeons can be educated in potential modifiable variables to improve the outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All ACL-deficient candidates scheduled for a revision ACL reconstruction at one of the participating MARS sites.
Key inclusion criteria (10 listed)
- All ACL-deficient candidates presenting to the clinic, between the ages of 12† and 65, scheduled to have a revision ACL reconstruction by a participating (MARS Study) surgeon.
- All participants must have undergone a primary ACL reconstruction in the past and are currently identified as having experienced failure of their primary ACL reconstruction, as defined by either MRI, knee laxity (KT > 5mm), a positive pivot shift or Lachman's, functional instability, and/or by arthroscopic confirmation.
- All ACL-deficient patients seeking a revision ACL reconstruction that have either partial (Grade I or II) and/or complete (Grade III) simultaneous ligamentous injuries to the collateral ligaments (MCL or LCL) and/or the posterior cruciate ligament (PCL) will also be included.
- Non-operative treatment of patients with ACLR failure are also eligible to participate.
- The following graft types will be the only ones accepted for inclusion:
Key exclusion criteria (3 listed)
- Patients presenting with prior infection, arthrofibrosis, or regional pain syndrome.
- Subjects will be excluded if their allograft source does not come from MTF.
- Patients unwilling or unable to complete their repeat questionnaire two years after their initial visit.
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
Graft re-rupture
Time frame: 2, 6, 10, and 20 years after revision ACL surgery
1 secondary outcome
Patient based outcome measures
Time frame: 2, 6,10, and 20 years after revision ACL surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 39555321MARS Group; Vasavada K, Vasavada V, Moran J, Devana S, Lee C, Hame SL, Jazrawi LM, Sherman OH, Huston LJ, Haas AK, Allen CR, Cooper DE, DeBerardino TM, Spindler KP, Stuart MJ, Ned Amendola A, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, David TS, Dunn WR, Flanigan DC, Frederick RW, Ganley TJ, Gatt CJ Jr, Gecha SR, Giffin JR, Hannafin JA, Lindsay Harris N Jr, Hechtman KS, Hershman EB, Hoellrich RG, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, Wright RW, York JJ. A Novel Machine Learning Model to Predict Revision ACL Reconstruction Failure in the MARS Cohort. Orthop J Sports Med. 2024 Nov 14;12(11):23259671241291920. doi: 10.1177/23259671241291920. eCollection 2024 Nov.
- Derived from this study: PubMed 29882693MARS Group; Cooper DE, Dunn WR, Huston LJ, Haas AK, Spindler KP, Allen CR, Anderson AF, DeBerardino TM, Lantz BBA, Mann B, Stuart MJ, Albright JP, Amendola AN, Andrish JT, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Bechler JR, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Campbell JD, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, Dahm DL, David TS, Flanigan DC, Frederick RW, Ganley TJ, Garofoli EA, Gatt CJ Jr, Gecha SR, Giffin JR, Hame SL, Hannafin JA, Harner CD, Harris NL Jr, Hechtman KS, Hershman EB, Hoellrich RG, Hosea TM, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Sherman OH, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, York JJ, Wright RW. Physiologic Preoperative Knee Hyperextension Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report From the MARS Group. Am J Sports Med. 2018 Oct;46(12):2836-2841. doi: 10.1177/0363546518777732. Epub 2018 Jun 8.
- Derived from this study: PubMed 27161867MARS Group. Meniscal and Articular Cartilage Predictors of Clinical Outcome After Revision Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Jul;44(7):1671-9. doi: 10.1177/0363546516644218. Epub 2016 May 9.
- Individual participant dataSharing planned: No
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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.
Rick W. Wright, M.D. principal investigator
Vanderbilt University Medical Center
Kurt P. Spindler, M.D. principal investigator
Vanderbilt University Medical Center
49 sites in 2 countries: 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, run by Vanderbilt University Medical Center at 49 sites in 2 countries.
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 10 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Graft re-rupture (time frame: 2, 6, 10, and 20 years after revision ACL 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 NCT00625885, 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 24 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.