Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe

NCT02978573 | Completed Phase 3

• 1 other identifier: PTC-0031 (PAS)
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.

Conditions

Osteoarthritis of First Metatarsalphalangeal Joint

Keywords

First MTP Joint; Hallux Rigidus; Hallux Limitus; Cartilage Replacement; Osteoarthritis; First MTP Joint Osteoarthritis; Big Toe Pain

Outcome Measures

Primary Outcomes (1)

• Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise

  1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed. 2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.

  5 year

Secondary Outcomes (3)

• Pain Scale (VAS)

  5 year

• Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)

  5 year

• Foot and Ankle Ability Measure (FAAM) Sports

  5 year

Study Arms (1)

Cartiva

EXPERIMENTAL

Cartiva Synthetic Cartilage Implant

Device: Cartiva

Interventions

Cartiva DEVICE

Cartiva Synthetic Cartilage Implant

Cartiva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.

You may not qualify if:

• Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.

Sponsors & Collaborators

• Cartiva, Inc.: lead

MeSH Terms

Conditions

Hallux Rigidus; Hallux Limitus; Osteoarthritis

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries; Arthritis; Rheumatic Diseases

Study Officials

• Judith Baumhauer, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: December 1, 2016
• Study Start: October 1, 2016
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share