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

Launched by INVIBIO LTD · Jan 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special plate called the CoLink® PCR MTP Plate, which is used in surgery to treat a condition known as hallux rigidus. Hallux rigidus is when the big toe joint becomes stiff due to arthritis and damage to the cartilage. The trial involves patients who are 18 years or older and need surgery to fix this issue. If you are a candidate for this treatment and are able to participate in follow-up visits, you might be eligible to join the study.

Participants in the trial will undergo standard surgery to remove damaged cartilage in the big toe joint and use the CoLink® plate to help fuse two bones together. Throughout the study, data will be collected to evaluate how well the plate works and how safe it is. It's important to know that certain individuals, such as those who have had previous surgeries on the foot or have specific health conditions, may not be eligible to participate. If you are interested and meet the criteria, you will need to provide written consent and be willing to attend all follow-up appointments after the surgery.

Gender

ALL

Eligibility criteria

• 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 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.
• Exclusion Criteria:
• • 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.