Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Osteoarthritis Clinical Trial

— MTP  

Official title:

Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01673347
• Other study ID #: 2010-182
• Secondary ID: ISO 13485
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 14, 2012
• Last updated: August 26, 2015
• Start date: September 2010
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.

Description:

A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic of stage 3 osteoarthritis of the great toe

• symptoms recalcitrant to nonoperative management as determined clinically by the pi

Exclusion Criteria:

• diabetes mellitus

• kidney insufficiency

• oa in the adjacent joints

• malignancy with in the past 10 yrs

• minors (< 18 yrs of age)

• pregnant women and fetus

• mentally disabled or cognitively impaired individuals

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Meniscal Allograft
Meniscal allograft

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Paul Fortin, MD	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cole BJ, Carter TR, Rodeo SA. Allograft meniscal transplantation: background, techniques, and results. Instr Course Lect. 2003;52:383-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TO PERFORM A SCIENTIFIC EVALUATIONOF THE EFFICACY, IN TERMS OF DECREASED PAIN AND INCREASED FUNCTIONALITY FOR THE PATIENT	VAS, FAOS	1-2 WEEKS, 6WKS, 3MO, 6MO. IYR, 2YR, 3YR, 4YR, 5YR	Yes

External Links

•   Beaumont Hospital