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

Osteochondral Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385642
• Other study ID #: 0MCM0107-2
• Status: Completed
• First received: December 15, 2017
• Last updated: April 13, 2018
• Start date: May 29, 2017
• Est. completion date: February 22, 2018

Study information

• Verified date: April 2018
• Source: Collagen Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 22, 2018
• Est. primary completion date: February 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteochondral Defect

Intervention

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

Locations

Country	Name	City	State
Hungary	Uzsoki Hospital	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Collagen Solutions

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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