Meniscus; Detachment, Current InjuryNCT03650374
Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity
A study testing Experimental Strength Training in people with Meniscus; Detachment, Current Injury, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Meniscus; Detachment, Current Injury
- What is being tested?
- Experimental Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Dec 2025
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is indicated for meniscal root repair
- Patient is indicated for meniscus transplant
- Patient is at least 18 years of age
- Patient is expected to survive at least 1 year beyond surgery
- Patient has intact lower extremities bilaterally
- Patient is willing to participate by complying with pre-and post-operative visit requirements
- Patient is willing and able to review and sign a study informed consent form
Who cannot join
- Lower extremity musculoskeletal defects
- Systemic neuromuscular disorders
- Failure to complete pre-operative BIDOEX strength assessment
- Failure to complete pre-operative self-assessment score intake forms
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity.
After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.
Read the detailed description
Group I will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. The experimental strength training will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.
- Conditions
- Meniscus; Detachment, Current Injury
- Being tested
- Standard of Care Rehabilitation, Experimental Strength Training
- Keywords
- Meniscus root tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care RehabilitationOther
Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.
Experimental Strength TrainingOther
Will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | standard of care postoperative rehabilitation. Receives: Other: Standard of Care Rehabilitation |
| Group 2 | Experimental | experimental strength training Receives: Other: Experimental Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
A patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
Measured: 6 Weeks, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Sep 2021
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus; Detachment, Current InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzalez-Lomas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650374
- Sponsor's protocol ID
- 18-01100
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PI (Dr. Lomas) will be the only individual viewing and handling IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity
- ClinicalTrials.gov ID
- NCT03650374
- Acronym / sponsor ID
- 18-01100
- Conditions
- Meniscus; Detachment, Current Injury
- Keywords
- Meniscus root tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity.
After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.
Detailed description
Group I will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. The experimental strength training will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Standard of Care Rehabilitationstandard of care postoperative rehabilitation. |
| Group 2 | Experimental | Other: Experimental Strength Trainingexperimental strength training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is indicated for meniscal root repair
- Patient is indicated for meniscus transplant
- Patient is at least 18 years of age
- Patient is expected to survive at least 1 year beyond surgery
- Patient has intact lower extremities bilaterally
Key exclusion criteria (4 listed)
- Lower extremity musculoskeletal defects
- Systemic neuromuscular disorders
- Failure to complete pre-operative BIDOEX strength assessment
- Failure to complete pre-operative self-assessment score intake forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care RehabilitationKnee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. | Other | Group 1 |
| Experimental Strength TrainingWill be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg. | Other | Group 2 |
Primary outcome
KOOS
Time frame: 6 Weeks, 3 Months, 6 Months
A patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
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 30 Mar 2026.
- Individual participant dataSharing planned: No. PI (Dr. Lomas) will be the only individual viewing and handling IPD
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.
Guillem Gonzalez-Lomas, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Strength Training in people with Meniscus; Detachment, Current Injury, run by NYU Langone Health at 1 site 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 7 inclusion and 4 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
KOOS (time frame: 6 Weeks, 3 Months, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.