Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 evaluatedas appropriate candidates for treatment with the CoLink® PCR MTP Plate by theInvestigator.
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.
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:
Subjects who have previously undergone MTP fusion surgery or implant arthroplasty inthe foot to be treated.
Subjects who require bi-lateral MTP fusion surgery.
Subjects with evidence of tumour and/or malignant disease with resultant lifeexpectancy 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 wouldcompromise their participation and follow-up in this clinical study.
Subjects who have any conditions outlined as contraindicated in the Instructions forUse.
Female subjects who are pregnant or lactating.
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.
Subjects who are current smokers or have stopped smoking less than 6 months ago.
Subjects who are currently enrolled in a clinical study.
Study Design
Connect with a study center
South Florida Foot and Ankle Center
Lake Worth, Florida 33462
United StatesActive - Recruiting
University of Kansas Medical Centre
Kansas City, Kansas 66160
United StatesActive - Recruiting
Mississippi Sports Medicine and Orthopedic Center,
Jackson, Mississippi 39202
United StatesActive - Recruiting
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