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Procedure

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
Body Mass Index ≤ 40 (BMI=kg/m2)
Has experienced pain in study knee for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up superiority will be statistically tested at month 12 at p<0.01
Awards & highlights

PRESERVE Knee Trial 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

PRESERVE Knee Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a body mass index (BMI) of less than 40.
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You have been feeling pain in your knee for at least 3 months.
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You need knee arthroscopy surgery because of problems like a torn meniscus, loose body, or inflammation in the joint.
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You must report moderate to extreme pain on at least one of the questions about pain during the preoperative study visit.
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The ligaments in your knee are strong and not injured.
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Your weight is within a healthy range for your height.
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You have been experiencing knee pain for at least 3 months.

PRESERVE Knee Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Clinical Success
Secondary outcome measures
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

PRESERVE Knee 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.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,299 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,990 Patients Enrolled for Osteoarthritis
MedNet SolutionsUNKNOWN
Medical Metrics Diagnostics, IncIndustry Sponsor
12 Previous Clinical Trials
1,571 Total Patients Enrolled
1 Trials studying Osteoarthritis
115 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

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

Are seniors eligible to participate in the investigation?

"Candidates for this research endeavour must be between 30 and 75 years of age."

Answered by AI

Are there multiple sites administering this investigation in the metropolis?

"This trial is being run at the New mexico Orthopaedic Fellowship Foundation in Albuquerque, CORE Orthopaedic Medical Center in Encinitas and Loma Linda University Health System in Loma Linda. An additional 13 medical centres are also included as locations for this study."

Answered by AI

What qualifications must I meet to join this clinical experiment?

"This clinical trial is recruiting 134 participants aged between 30 and 75 years old who have arthrosis. Eligible candidates must satisfy the following: Grade 1-3 Osteoarthritis in the study knee as seen on preoperative XR imaging, Single BML of tibia or adjoining BML's of tibia & femur, Informed Consent approved by IRB/REB, BMI ≤ 40 (kg/m2), Have experienced pain in the study knee for at least 3 months, White signal present on T2 weighted or Proton Density MR Imaging confirming a BML, Surgical candidate due to mechanical symptoms such"

Answered by AI

Are there current openings to join this experiment?

"As per clinicaltrials.gov, this study is not taking new patients at the moment. The trial was initially published on March 29th 2017 and last modified on October 19th 2022. However, there are currently 704 other trials searching for participants now."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Georgia
California
How old are they?
65+
What site did they apply to?
Stanford University
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Anything to avoid further surgery. Had a TKR in 2016 and the hardware slipped necessitating a revision of the left knee. Fell and tore my quads - Michael Jacobs did the revision and Thomas Ring did the quad repair. That did not work so had surgery in October 2021 with Ron Delanois at Lifebridge to repair the quads. Been compensating when sitting and standing and my right knee has pain.
PatientReceived no prior treatments
~17 spots leftby Mar 2025