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

Inclusion criteria

• Subjects aged 18 years of age or older (> 18 years) and are skeletally mature.
• 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.
• 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.
• 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

• Subjects who have previously undergone MTP fusion surgery or implant arthroplasty in the foot to be treated.
• Subjects who require bi-lateral MTP fusion surgery.
• Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
• Subjects with a known allergy to the material used in the instrumentation.
• Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
• Female subjects who are pregnant or lactating.
• 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.
• Subjects who are current smokers or have stopped smoking less than 6 months ago.
• Subjects who are currently enrolled in a clinical study.