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

NCT03385642 | Completed

• 1 other identifier: 0MCM0107-2
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteochondral Defect

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Chondromimetic

Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107

Device: ChondroMimetic

Interventions

ChondroMimetic DEVICE

ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee

Chondromimetic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Collagen Solutions: lead

Study Sites (1)

Uzsoki Hospital

Budapest, Hungary

Location

Study Officials

• Laszlo Hangody, MD, PhD, DSc

  Uzsoki Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 28, 2017
• Study Start: May 29, 2017
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)