Clinical trial NCT05692687: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hallux Rigidus
Lead sponsor: Invibio Ltd
Sponsor class: INDUSTRY
Collaborators: name: In2Bones
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective study so patients taken from those undergoing treatment surgery for Hallux Rigidus.

Brief 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 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.

Primary outcomes:
measure: Bone Fusion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: South Florida Foot and Ankle Center
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Centre
state: Kansas
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopedic Center,
state: Mississippi
Study officials:
References: