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Procedure

Surgery vs Pain Management for Torn Meniscus

N/A

Recruiting

Led By Jorge Chahla, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 12 months postoperatively (18 months if crossover at 3 months from arm 1 to arm 2)

Awards & highlights

Study Summary

This trial examines pain, function, and imaging of knee injuries, to understand natural history of meniscal root tears and their repair, and to identify risk factors for poorer outcomes & OA.

Who is the study for?

This trial is for adults with an MRI-confirmed isolated tear in the medial meniscus root of the knee. Candidates must be able to complete questionnaires and undergo post-treatment imaging. People with additional serious knee injuries, advanced osteoarthritis, or conditions that make surgery or physical therapy risky cannot participate.Check my eligibility

What is being tested?

The study compares two approaches for treating a torn meniscus: surgical repair within three weeks of joining the trial versus non-operative pain management. The goal is to assess differences in pain relief, functional outcomes reported by patients, and changes seen on imaging over time.See study design

What are the potential side effects?

Surgical repair may lead to risks such as infection, blood clots, persistent knee pain or stiffness, and complications from anesthesia. Non-operative treatment might not provide adequate pain relief or could potentially lead to further joint damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 12 months postoperatively (18 months if crossover at 3 months from arm 1 to arm 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 12 months postoperatively (18 months if crossover at 3 months from arm 1 to arm 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 12 months postoperatively (18 months if crossover at 3 months from arm 1 to arm 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual analogue scale (VAS) for pain

Secondary outcome measures

European Quality of Life Scale (Euro-QoL)

Knee Osteoarthritis and Outcomes Score (KOOS)

Lysholm knee score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Operative Intervention (ARM 2)Experimental Treatment1 Intervention

Subjects randomized to the operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment. All surgically treated subjects, regardless if repairs were performed acutely or after cross over, will receive identical postoperative rehabilitation.

Group II: Non-operative Control (ARM 1)Active Control1 Intervention

Subjects randomized to the non-operative treatment arm will receive analgesics, physical therapy and will remain non-weight bearing. This will consist in anti-inflammatory drugs daily for 8-12 weeks and supervised physical therapy at least twice a week over a period of 8 weeks. Subjects in the non-operative arm will be offered the opportunity to crossover to the operative arm (ARM 2) of the study if the subjects do not report symptomatic improvement within 3 months after entry in this study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)UNKNOWN

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,361 Total Patients Enrolled

Jorge Chahla, MDPrincipal InvestigatorRush University Medical Center Associate Professor and Surgeon

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Operative Treatment (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05985772 — N/A

Torn Meniscus Research Study Groups: Non-operative Control (ARM 1), Operative Intervention (ARM 2)

Torn Meniscus Clinical Trial 2023: Operative Treatment Highlights & Side Effects. Trial Name: NCT05985772 — N/A

Operative Treatment (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on the number of individuals participating in this research?

"Affirmative. The information available on clinicaltrials.gov confirms that this trial is actively seeking enrolment, with the first post dated April 20th 2022 and most recent update August 9th 2023. In total, 140 patients need to be sourced from 1 location."

Answered by AI

Are there still opportunities to take part in this research initiative?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research is currently recruiting participants, with an initial posting date of April 20th 2022 and a most recent update from August 9th 2023. 140 individuals are required to partake in the study at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)

2022. "Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05985772.