Subchondroplasty Procedure in Patients With Bone Marrow Lesions

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03430219
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	March 1, 2018
Completion date	March 16, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03110224` - SCP® Observational Study of the Knee
Recruiting	`NCT03699046` - Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee	N/A
Recruiting	`NCT05596591` - Focused Extracorporeal Shockwave Therapy for Knee Arthritis	N/A
Completed	`NCT03941977` - Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting	N/A
Completed	`NCT01348269` - Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome	Phase 3
Recruiting	`NCT04895228` - Impact of Sacroiliac Joint Injection on Bone Marrow Edema	N/A
Completed	`NCT03112200` - Subchondroplasty® Knee RCT	N/A
Active, not recruiting	`NCT03494660` - SCP Hip Outcomes Study
Completed	`NCT01621893` - Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions
Terminated	`NCT03112122` - Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute	Phase 4
Recruiting	`NCT03921489` - Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
Terminated	`NCT03829644` - Lumbar Bracing for People With Type I Modic Changes	N/A
Recruiting	`NCT04963127` - Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema
Completed	`NCT04905394` - Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee	N/A