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NCT05692687

A Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

Sponsor: Invibio Ltd

View on ClinicalTrials.gov

Summary

The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage). It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate).

Official title: A Prospective, Non-comparative, Multi-centre, Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

18

Start Date

2023-03-15

Completion Date

2025-08-12

Last Updated

2026-09-10

Healthy Volunteers

No

Conditions

Locations (3)

South Florida Foot and Ankle Center

Lake Worth, Florida, United States

University of Kansas Medical Centre

Kansas City, Kansas, United States

Mississippi Sports Medicine and Orthopedic Center,

Jackson, Mississippi, United States