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Intratendinous Genipin Injection in Horses With Tendon Injuries

Primary Purpose

Superficial Digital Flexor Tendonitis

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Genipin
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Digital Flexor Tendonitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Equine surgery, Vetsuisse-Faculty, University of Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intratendinous genipin injection

Arm Description

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 .

Outcomes

Primary Outcome Measures

Recovery from tendon injury
The amount of horses that regain AAEP lameness grade 0 (sound; free of lameness) after superficial digital flexor tendon injury

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
February 22, 2023
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05755750
Brief Title
Intratendinous Genipin Injection in Horses With Tendon Injuries
Official Title
Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2016 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our study is the first to use genipin, a naturally occurring collagen cross-linking agent, as a therapeutic agent to treat superficial digital flexor tendon (SDFT) injuries in horses. The promising approach of intratendinous genipin injection and tendon mechanical enhancement could be a viable alternative to current therapies for SDFT injuries.
Detailed Description
Tendon injuries are a career limiting or ending condition in horses. Genipin (GP), an exogenous collagen crosslinker, provides ex-vivo tendon mechanical augmentation and excellent biosafety. The main objective of this study is to investigate treatment success of GP-induced collagen crosslinking in a clinical application in horses with superficial digital flexor tendon (SDFT) injuries. Horses with an AAEP (American Association of American Practitioners) lameness score > 0 and sonographically confirmed tendinopathy are treated with intratendinous GP injection (IGI) and controlled exercise. Minimal follow-up was set at 12 months. Outcome factors are lameness (AAEP lameness score), soundness, assessment of return to previous use, and re-injury. Additionally, adverse effects are recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Digital Flexor Tendonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intratendinous genipin injection
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Genipin
Other Intervention Name(s)
Methyl (1R,4aS,7aS)-1-hydroxy-7-(hydroxymethyl)-1,4a,5,7a-tetrahydrocyclopenta[c]pyran-4-carboxylate
Intervention Description
Intratendinous genipin injection
Primary Outcome Measure Information:
Title
Recovery from tendon injury
Description
The amount of horses that regain AAEP lameness grade 0 (sound; free of lameness) after superficial digital flexor tendon injury
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fürst Anton, Prof Dr.
Organizational Affiliation
Professor, Head of Department
Official's Role
Study Director
Facility Information:
Facility Name
Equine surgery, Vetsuisse-Faculty, University of Zurich
City
Zürich
State/Province
ZH
ZIP/Postal Code
8057
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intratendinous Genipin Injection in Horses With Tendon Injuries

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