Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee

Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)

To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

Study Overview

• Status: Completed
• Conditions: Osteochondral Defect
• Intervention / Treatment: Device: ChondroMimetic

Detailed Description

This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Uzsoki Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects were treated with a Chondromimetic device under Protocol 0MCM0107

Description

Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chondromimetic; Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107	Device: ChondroMimetic; ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from 0MCM0107 baseline in Modified Cincinnati Rating System	Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.	0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
KOOS (Knee injury and Osteoarthritis Outcome Score	Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.	Through study completion, an average of approximately 8 years follow-up
Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis	Morphological segmentation utilizing a programmed anatomical atlas for all bone and cartilage structures will be used to assess defect filling (using previous MRI scans from study 0MCM0107 as reference), and T2 mapping for cartilage repair tissue quality.	Through study completion, an average of approximately 8 years follow-up
Osteochondral defect repair assessment	Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system.	Through study completion, an average of approximately 8 years follow-up
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107	0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up

Collaborators and Investigators

• Sponsor: Collagen Solutions
• Investigators: Principal Investigator: Laszlo Hangody, MD, PhD, DSc, Uzsoki Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2017
• Primary Completion (Actual): February 22, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: 0MCM0107-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No