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

Last updated: April 29, 2025
Sponsor: Invibio Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05692687
IN2B01
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion 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 evaluatedas appropriate candidates for treatment with the CoLink® PCR MTP Plate by theInvestigator.

  3. Subjects who, in the opinion of the Investigator, are able to understand thisclinical study, co-operate with the procedures and are willing to return to thehospital for all the required post-operative follow-ups.

  4. Subjects who are able to give voluntary, written informed consent to participate inthis clinical study and from whom consent has been obtained.

Exclusion

Exclusion Criteria:

  1. Subjects who have previously undergone MTP fusion surgery or implant arthroplasty inthe 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 lifeexpectancy 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 wouldcompromise their participation and follow-up in this clinical study.

  6. Subjects who have any conditions outlined as contraindicated in the Instructions forUse.

  7. Female subjects who are pregnant or lactating.

  8. Subjects who are known drug or alcohol abusers, or with a baseline opioid usegreater than 30 mg of morphine equivalent/day, or with psychological disorders thatcould 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.

Study Design

Total Participants: 40
Study Start date:
March 15, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • South Florida Foot and Ankle Center

    Lake Worth, Florida 33462
    United States

    Active - Recruiting

  • University of Kansas Medical Centre

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Mississippi Sports Medicine and Orthopedic Center,

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

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