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

NCT05692687 | Completed

• 1 other identifier: IN2B01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

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).

Conditions

Hallux Rigidus

Outcome Measures

Primary Outcomes (1)

• Bone Fusion

  Successful radiographic union: where union is defined as 'evidence of bridging' between the metatarsal bone and proximal phalanx bone by an independent imaging company.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective study so patients taken from those undergoing treatment surgery for Hallux Rigidus.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invibio Ltd: lead
• In2Bones: collaborator

Study Sites (3)

South Florida Foot and Ankle Center

Lake Worth, Florida, 33462, United States

Location

University of Kansas Medical Centre

Kansas City, Kansas, 66160, United States

Location

Mississippi Sports Medicine and Orthopedic Center,

Jackson, Mississippi, 39202, United States

Location

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: March 15, 2023
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)