Intratendinous Genipin Injection in Horses With Tendon Injuries
Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
ZH
-
Zürich, ZH, Switzerland, 8057
- Equine surgery, Vetsuisse-Faculty, University of Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical and sonographic evidence of a tendon injury
Exclusion Criteria:
- in the final analysis, only superficial digital flexor tendon injuries were included
- if follow-up was less than 12 m due to euthanasia, death or other reasons, horses were excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intratendinous genipin injection
Genipin was administrated intratendinously under sonographic guidance. For lesions up to 3 cm in length, two separate 0.2 ml injections of genipin solution were administered into the region of transition from degenerated to normal tendon tissue. One injection was given at the proximal end of the lesion and the other at the distal end. For lesions longer than 3 cm, an additional 0.2 ml injection was used for every additional 3 cm of lesion length. In the illustrated example, the 6 cm lesion required a total of three injections, and therefore one additional injection was given in the middle of the lesion between the distal and proximal injections. Genipin treatment solution contained 100 mM genipin and 20% of the solvent dimethyl sulfoxidee in phosphate buffered saline. Instead of one administration of a relatively large volume, several individual administrations of 0.2 ml were performed depending on lesion size . |
Intratendinous genipin injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery from tendon injury
Time Frame: 12 months
|
The amount of horses that regain AAEP lameness grade 0 (sound; free of lameness) after superficial digital flexor tendon injury
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fürst Anton, Prof Dr., Professor, Head of Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Genipin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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