Intratendinous Genipin Injection in Horses With Tendon Injuries

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Genipin

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

NCT ID

NCT05755750

First Posted

February 9, 2023

Last Updated

February 22, 2023

Sponsor

University of Zurich

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

Superficial Digital Flexor Tendonitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial