Arthroscopic Partial Meniscectomy in Osteoarthritis: A Randomized Control Trial

Institutional Review Board, Hospital for Special Surgery

December 10, 2008

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Lisa A. Mandl, MD, MPH

Co-Investigators

Answorth A. Allen, MD
Stuart Davidson
Danielle Edwards  
Jo A. Hannafin, MD, PhD   
Jeffrey Katz, MD, MS  (Brigham and Women’s Hospital, Boston, MA)
Alejandro Leali, MD
Robert G. Marx MD, MSc, FRCSC
Andrew D. Pearle, MD
Jennifer Petrakis, DPT, MLT
Scott A. Rodeo, MD
Russell F. Warren, MD
Riley J. Williams III, MD

Summary

70 subjects will be recruited and randomly assigned to either physical therapy or surgery. The total duration of participation will be 2 years for each patient, which includes 2 visits and 3 mailings. Subjects will be screened for eligibility by an initial consultation with one of the study doctors. We are recruiting from the present to May of 2010.

Inclusion/Exclusion Criteria

Criteria for inclusion:

• Symptoms for at least 1 month
• Symptoms with a mechanical quality (at least one of: clicking, catching, popping, giving way, pain with pivot or torque, pain that is episodic, pain that is acute and localized to one joint line)
• Evidence on knee MRI of osteophyte formation or cartilage signal abnormality, or plain radiographic evidence of osteophyte or joint space narrowing
• Evidence on knee MRI of a meniscal tear (tear extends to surface of meniscus)
• Willingness to be randomized and ability to understand and sign an informed consent document

Exclusion Criteria:

• A chronically locked knee (i.e. knee cannot bend)
• Symptoms from another source (ie: Patellofemoral syndrome, symptomatic ligament tear, other)
• Psychologic issues that preclude participation
• Kellgren and Lawrence Grade IV (This is far advanced osteoarthritis and total knee replacement is typically more sensible in this setting)
• Clinically symptomatic chondrocalcinosis (i.e. pseudogout)
• Injection with viscosupplementation (i.e. synvisc, orthovisc) in past four weeks
• Medical contraindications to surgery
• Surgery planned for both knees if randomized to surgery arm
• Unable or unwilling to give informed consent
• Inability to safely perform MRI imaging
• Unable or unwilling to attend outpatient physical therapy sessions on a regular basis.

Contact Information

Stuart Davidson, Clinical Research Coordinator
212.774.2960
DavidsonS@hss.edu