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

Description

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).

Conditions

Hallux Rigidus

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Hallux Rigidus
Intervention / Treatment

-

Contacts and Locations

Lake Worth

South Florida Foot and Ankle Center, Lake Worth, Florida, United States, 33462

Kansas City

University of Kansas Medical Centre, Kansas City, Kansas, United States, 66160

Jackson

Mississippi Sports Medicine and Orthopedic Center,, Jackson, Mississippi, United States, 39202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects aged 18 years of age or older (\> 18 years) and are skeletally mature.
  • 2. Subjects who require surgical treatment for hallux rigidus and have been evaluated as appropriate candidates for treatment with the CoLink® PCR MTP Plate by the Investigator.
  • 3. Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • 4. Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
  • 1. Subjects who have previously undergone MTP fusion surgery or implant arthroplasty in the foot to be treated.
  • 2. Subjects who require bi-lateral MTP fusion surgery.
  • 3. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
  • 4. Subjects with a known allergy to the material used in the instrumentation.
  • 5. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
  • 6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
  • 7. Female subjects who are pregnant or lactating.
  • 8. Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
  • 9. Subjects who are current smokers or have stopped smoking less than 6 months ago.
  • 10. Subjects who are currently enrolled in a clinical study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Invibio Ltd,

Study Record Dates

2025-11