NCT03430219

Subchondroplasty Procedure in Patients With Bone Marrow Lesions

Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, post-market data collection study intended to collect data on the short- and long-term safety and performance of the SCP Procedure.

Detailed description

Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 95 patients across 4 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years. Follow-up assessments will be conducted at 1 month, 3, 6, 12-months and 24-months post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes. For all subjects at selected centers, a long standing X-ray and MRI at screening and either at 12 months or 24 months will be obtained.

Conditions

• Bone Marrow Lesions
• Bone Marrow Edema

Interventions

Type	Name	Description
DEVICE	Subchondroplasty Procedure	AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure

Timeline

• Start date: 2018-03-01
• Primary completion: 2023-03-16
• Completion: 2023-03-16
• First posted: 2018-02-12
• Last updated: 2023-06-22

Locations

6 sites across 5 countries: Germany, Italy, Netherlands, Spain, United Kingdom