Evaluating a new plate for treating big toe arthritis

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

This study is testing a new plate to see if it can help people with stiff big toe arthritis feel better after surgery.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Invibio Ltd (Industry-sponsored)
• Locations: 3 sites (Lake Worth, Florida and 2 other locations)
• Trial ID: NCT05692687 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and performance of the CoLink® PCR MTP Plate in treating hallux rigidus, a condition characterized by stiffness in the big toe joint due to arthritis. The study involves routine surgical procedures where damaged cartilage is removed, and the bones are fixed together using the plate. Data will be collected from skeletally mature patients who are appropriate candidates for this treatment, following standard surgical practices. The goal is to assess the effectiveness of this specific implant in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who require surgical treatment for hallux rigidus and are suitable for the CoLink® PCR MTP Plate.

Not a fit: Patients who have previously undergone MTP fusion surgery or have a known allergy to the materials used in the plate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and pain relief for patients suffering from hallux rigidus.

How similar studies have performed: While this approach is based on established surgical practices, the specific use of the CoLink® PCR MTP Plate in this context is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Lake Worth, Florida and 2 other locations

• South Florida Foot and Ankle Center — Lake Worth, Florida, United States (Recruiting)
• University of Kansas Medical Centre — Kansas City, Kansas, United States (Recruiting)
• Mississippi Sports Medicine and Orthopedic Center, — Jackson, Mississippi, United States (Recruiting)

Study contacts

• Study coordinator: Karen 2 Robson

Conditions Hallux Rigidus