In an increasingly cost-conscious and data driven healthcare-solutions market, Zimmer Biomet aims to provide high-quality clinical data to demonstrate the safety, effectiveness and value of its products and services.

The Subchondroplasty (SCP®) procedure is performed using commercially-available devices which are registered and/or cleared by the FDA as is appropriate for the class of the device.

PRESERVE-Knee Study

Protocol: A Randomized Controlled Trial of the Subchondroplasty Procedure With Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow Lesions in the Knee.

The purpose of this study is to measure if there is an advantage of the Subchondroplasty Procedure with arthroscopy compared to arthroscopy alone in subjects with a bone marrow lesion (BML). Determining if one procedure is better than the other will be measured in terms of whether or not enrolled subjects require an additional surgical intervention, after they have had the proposed procedure.

The PRESERVE - Knee Study is a clinical research study involving 201 patients with BML in the knee.

There will be two patient groups in this study. Study participants will be randomly assigned to receive either the Subchondroplasty procedure with arthroscopy (study group) or arthroscopy alone (control group). Participants will be two times more likely to receive the Subchondroplasty procedure with arthroscopy versus arthroscopy alone.

Enrolled patients will be asked to return to their doctor’s office for five follow-up visits scheduled at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Patients will complete questionnaires at each of these visits which will ask for information about their pain, function, and general health. Patients will also receive two follow-up phone calls at 9 and 18 months to monitor their progress.

This study is currently active and open to enrollment.

Learn More clinicaltrials.gov

SCP Hip Outcomes Study

Protocol: A Longitudinal Outcomes Study of the Subchondroplasty Procedure in the Hip

The purpose of this research is to understand the post-operative outcomes of patients choosing to undergo the Subchondroplasty (SCP) Procedure, where subchondral bone defects will be filled in the hip. Subchondral bone defects are abnormal areas of bone in the hip that have been shown to be linked to pain. Patient reported outcomes (PROs) are questionnaires that ask patients about their hip from their point of view both before and after surgery. This study uses a series of PROs to learn how subjects feel about hip pain and function. We expect that patients taking part in this research will participate for approximately 5 years.

This is not a treatment study, but a data gathering study of information before and after surgery. About 100 subjects will take part in this research.

This study is currently active and open to enrollment.

clinicaltrials.gov

SCP Foot/Ankle Outcomes Study

Protocol: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle

The purpose of this research is to understand the post-operative outcomes of patients choosing to undergo the Subchondroplasty (SCP) Procedure, where subchondral bone defects will be filled in the foot and/or ankle. Subchondral bone defects are abnormal areas of bone in the hip that have been shown to be linked to pain. Patient reported outcomes (PROs) are questionnaires that ask patients about their foot and/or ankle from their point of view both before and after surgery. This study uses a series of PROs to learn how subjects feel about foot and ankle pain and function. We expect that patients taking part in this research will participate for approximately 5 years.

This is not a treatment study, but a data gathering study of information before and after surgery. Up to 250 subjects will take part in this research.

This study is currently active and open to enrollment.

clinicaltrials.gov

SCP Observational Study of the Knee

Protocol: Zimmer Knee Creations SCP Observational Cohort Follow-Up Study

This is a post-market, multi-center, patient outcomes centered study to evaluate the postoperative outcomes of subjects choosing to undergo the Subchondroplasty (SCP) procedure. Enrolled patients will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion (BML) in the knee. Demographics, medical history and medications will be recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures preoperatively, as well as post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years.

This study is currently active, but is closed to enrollment.

clinicaltrials.gov

SCP Prospective Study of the Knee

Protocol: Evaluation of Subchondroplasty for Defects Associated With Bone Marrow Lesions

This study is a prospective, consecutive series outcomes study investigating long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure, including changes in pain, function, and overall health. Patients presenting with knee pain associated with bone marrow lesions that meet the inclusion criteria will be eligible to undergo the Subchondroplasty procedure, and will be followed for 24 months after surgery via office visits. Patients will also be contacted once per year for up to 5 years post-operatively and asked questions regarding their pain and functioning to further understand long-term outcomes. The study is intended to provide an estimate of one-year and two-year clinical success and comparison to commonly accepted two-year clinical success rates for currently available treatment alternatives.

This study is currently active, but is closed to enrollment.

clinicaltrials.gov