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Knee surgery tension: a hidden key to arthritis prevention?

NCT ID NCT00434837

Disease control Sponsor: Rhode Island Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study looks at whether the amount of tension applied to a new ACL graft during knee surgery influences the development of arthritis over at least 15 years. About 168 people with a torn ACL in one knee will be followed, comparing two common tension settings. The goal is to see if one method better preserves joint space and reduces arthritis signs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Initial graft tension during ACL reconstruction surgery
What this could lead to
If one tension method proves better, it could guide surgeons to reduce the long-term risk of knee arthritis after ACL reconstruction.
What could go wrong
This is a long-term observational comparison of two common techniques, so results may take years and could show no clear difference. Individual outcomes vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

168 people

The number who actually took part.

Started

Feb 2004

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Groups 1 and 2: * ACL injury of only one knee (minor meniscal tears involving less than 1/3 of the meniscus are allowed) * Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles) * Tegner activity score of 5 or greater, indicating participant is at least moderately active Exclusion Criteria for Groups 1 and 2: * ACL tear that has occurred more than 12 months prior to surgery * Moderate-sized fissures or lesions in knee articular cartilage * Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus) Inclusion Criteria for the Control Group: * Tegner activity score of 5 or greater, indicating participant is at least moderately active Exclusion Criteria for All Participants: * Previous injury to either knee * Increased laxity of the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL), as compared to the uninjured knee * Radiographic evidence of degenerative arthritis * Pregnancy * Any disease that might place a participant at high risk for articular cartilage damage (e.g., rheumatoid arthritis, osteoporosis, metabolic diseases)

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries osteoarthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior cruciate ligament rupture

Contacts and locations

Locations

  • Miriam Hospital/Brown University

    Providence, Rhode Island, 02906, United States

  • Rhode Island Hospital/Brown University

    Providence, Rhode Island, 02903, United States

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