Subchondroplasty with Arthroscopy for Osteoarthritis (PRESERVE Knee Trial)

N/A

Waitlist Available

Led By Jason Dragoo, MD

Research Sponsored by Zimmer Biomet

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 superiority will be statistically tested at month 12 at p<0.01

Summary

This trial is a study to compare two methods of treating bone marrow lesions in the knee, one with a Subchondroplasty + Arthroscopy and the other with just Arthroscopy. The study will have 134 subjects total and it is prospective, single-blinded, and two-arm.

Eligible Conditions

Osteoarthritis of the Knee
Osteoarthritis
Bone Marrow Edema
Chronic Knee Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ superiority will be statistically tested at month 12 at p<0.01

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~superiority will be statistically tested at month 12 at p<0.01

This trial's timeline: 3 weeks for screening, Varies for treatment, and superiority will be statistically tested at month 12 at p<0.01 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Clinical Success

Secondary study objectives

Change from baseline EQ-5D score at 12 Months

Change from baseline Global Satisfaction score at 12 Months

Change from baseline KOOS subscale scores at 12 Months

+10 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Subchondroplasty with ArthroscopyActive Control1 Intervention

After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.

Group II: Arthroscopy AlonePlacebo Group1 Intervention

After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures: * Partial meniscectomy * Lavage * Debridement * Loose body removal * Synovectomy * Removal of osteophytes in the notch or locations other than those adjacent to BML(s) Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.

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