Group II for Osteochondral Defect

St. Paul's Hospital, Vancouver, Canada
Osteochondral DefectBioCartilage® Micronized Cartilage Matrix - Device
Eligibility
18+
All Sexes

Study Summary

This trial tests whether adding a cartilage matrix product to microfracture treatment of ankle cartilage defects improves healing and pain/function.

Eligible Conditions
  • Osteochondral Defect

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: There are 6 assessment time points: within 21 days of surgery, 6 weeks post-op, 12 weeks post-op, 6 months post-op, 1 year post-op and 2 years post-op.

Year 2
Changes as Assessed by Ankle Osteoarthritis Scale (AOS)
Ankle
Musculoskeletal System
Visual Analog Scale
Year 2
CT radiographic assessments performed pre-operatively and post-operatively
MRI radiographic assessments performed pre-operatively and post-operatively
Year 2
X-ray radiographic assessments performed pre-operatively and post-operatively

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group I
1 of 2
Group II
1 of 2

Active Control

15 Total Participants · 2 Treatment Groups

Primary Treatment: Group II · No Placebo Group · N/A

Group INoIntervention Group · 1 Intervention: Group I · Intervention Types:
Group II
Device
ActiveComparator Group · 1 Intervention: BioCartilage® Micronized Cartilage Matrix · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: there are 6 assessment time points: within 21 days of surgery, 6 weeks post-op, 12 weeks post-op, 6 months post-op, 1 year post-op and 2 years post-op.

Who is running the clinical trial?

St. Paul's Hospital, CanadaLead Sponsor
43 Previous Clinical Trials
12,155 Total Patients Enrolled
Arthrex, Inc.Industry Sponsor
42 Previous Clinical Trials
29,347 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your foot is not too angled inward or outward.
You have a long-term medical issue that wasn't caused by a recent injury within the past 6 months.
If you have had a bone fracture in the past, it must have healed properly without any remaining deformity in your leg bones or ankle joint.
You have already tried all available treatments that do not involve surgery.
You have been experiencing symptoms for less than a year.
References

Frequently Asked Questions

Is enrollment for this study still available to participants?

"Affirmative. The information posted on clinicaltrials.gov verifies that this research is actively seeking participants, with the first posting having been made on January 29th 2019 and most recently updated April 2nd of last year. This study requires 15 individuals to be recruited from 1 medical centre." - Anonymous Online Contributor

Unverified Answer

How many participants are included in the clinical trial?

"Affirmative. According to information located on clinicaltrials.gov, this medical experiment is still searching for participants since its initial posting on January 29th 2019 and the latest update being April 2nd 2019. The study requires 15 patients from a single location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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