The Subchondroplasty Procedure is a minimally-invasive, fluoroscopically-assisted procedure that targets and fills subchondral bone defects through the delivery of AccuFill® Bone Substitute Material (BSM), a nanocrystalline, highly porous injectable calcium phosphate (CaP).
The SCP Procedure is usually performed along with arthroscopy for visualization and treatment of findings inside the joint. In some cases, an open or mini-open procedure is necessary for access to the defect.
Subchondral bone defects filled with bone substitute material during the SCP Procedure may include:
– Chronic bone marrow lesions with/without associated cysts.
– Insufficiency fractures of trabecular bone.
Bone Marrow Lesions (BML) are MRI-visible defects in the subchondral bone. BML can only be seen on fat-suppressed MRI sequences (T2FS, PDFS, etc.) where they appear as a hazy white area against the background of darker bone. Pathologists have shown that BML represent a healing response to trauma such as micro trabecular fractures of the subchondral bone.1
In these patients, current treatment guidelines recommend an initial course of conservative care which may heal the defect. If the defect remains, The SCP Procedure may be an option.
During The SCP Procedure, AccuFill BSM, an injectable, flowable, engineered calcium phosphate bone substitute is used to fill a subchondral bone defect. AccuFill® BSM crystallizes and hardens in an endothermic reaction at 37° C to form a nanocrystalline, macroporous scaffold in the bone. Over time, through cell-mediated remodeling, AccuFill BSM is resorbed and replaced with new bone.
To learn more about The SCP Procedure, visit the Zimmer Biomet Institute Calendar of Courses for a listing of Seminars and Hands-on Bioskills Workshops.
AccuFill BSM is an engineered calcium phosphate mineral compound.2 It flows readily to fill subchondral defects, crystallizes and hardens quickly in an endothermic reaction at 37° C to form a nanocrystalline, macroporous scaffold in the bone. Over time, through cell-mediated remodeling, AccuFill BSM is resorbed and replaced with new bone.
Important Information: The use of AccuFill BSM is not intended to be intrinsic to the stability of the bony structure. Radiographic studies should be used to confirm that the adjacent cortical bone is intact.
Criteria |
Feature |
Benefit |
Formulation |
Proprietary next generation apatite. |
Facilitates cell-mediated remodeling. |
Handling |
Truly injectable. |
No need to remove subchondral bone. |
Setting |
Endothermically sets in 10 minutes at 37°C. |
Sets hard after closure, no thermal necrosis. |
Structure |
Osteoconductive. |
Nanocrystalline structure and high surface area facilitate remodeling and bony ingrowth. |
Remodeling |
Cell-mediated remodeling. |
Remodels with new bone growth. |
AccuFill BSM is manufactured by Etex, a subsidiary of Zimmer Biomet and leader in bioresorbable bone substitute materials. The company is headquartered in MIT´s University Park in Cambridge, Massachusetts, a world renowned center for biotech research and innovation.
*M = metal ions
AccuFill Injectable Bone Substitute Material is an injectable, self-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Patients typically present with:
Discuss all treatment options with your patient. All surgical procedures carry a certain level of risk. A complete assessment of possible risks should be discussed before making the decision to have surgery.
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.
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.
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.
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.
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.
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.
