The Subchondroplasty® (SCP®) Procedure

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.

Overview

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.

  • Injected AccuFill BSM is replaced with new bone during the healing process.
  • The procedure is usually performed along with arthroscopy to aid in visualization, the SCP procedure does not inhibit the treatment of other findings inside the hip joint when performed along with arthroscopy.
  • SCP Procedure does not preclude future procedures. Should it become necessary, future surgery is still an option.

Chronic Bone Marrow Lesions (BML)

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

Subchondroplasty Knee MRI 1 1000x1000
Subchondroplasty Knee MRI 2 1000x1000
MRI of chronic Bone Marrow Lesions

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 Bone Substitute Material (BSM)

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.

Subchondroplasty Knee AccuFill Preparation Banner

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.

AccuFill® BSM Performance

Criteria

Feature

Benefit

Formulation

Proprietary next generation apatite.
Mimics chemical structure of human bone.

Facilitates cell-mediated remodeling.

Handling

Truly injectable.
Remains cohesive.
Flowable inside cancellous bone.
15 minutes of working time.

No need to remove subchondral bone.
No phase separation from injection pressure.
Interdigitates easily for complete defect fill.
Long window for implantation; intraoperative flexibility.

Setting

Endothermically sets in 10 minutes at 37°C.

Sets hard after closure, no thermal necrosis.

Structure

Osteoconductive.
Nanocrystalline structure.
65% total porosity; 1-300 μm pore size.
10 MPa compressive strength.

Nanocrystalline structure and high surface area facilitate remodeling and bony ingrowth.
Physical properties comparable to cancellous bone.

Remodeling

Cell-mediated remodeling.
Remodeled vs. dissolved.

Remodels with new bone growth.

AccuFill® BSM = Ca10-x(M)x(PO4)6-x(HPO4,CO3)x(OH)2-x = Bone*2

AccuFill BSM is manufactured by Etex, a subsidiary of Zimmer Biomet and leader in bioresorbable bone substitute materials.

*M = metal ions

Indications for Use:

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.

Clinical Studies

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.

  1. Eriksen EF, Ringe JD. Bone marrow lesions: a universal bone response to injury? Rheumatol Int. 2012;32(3):575–584.
  2. Tofighi, et al. New Generation of Synthetic, Bioresorbable and Injectable Calcium Phosphate Bone Substitute Materials: Alpha-bsm, Beta-bsm and Gamma- bsm; JBBTE. 2009; 2:39.

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