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

Hallux Rigidus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692687
• Other study ID #: IN2B01
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2023
• Source: Invibio Ltd
• Contact: Karen 2 Robson
• Phone: +447765220492
• Email: karen.robson[@]invibio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Locations

Country	Name	City	State
United States	Mississippi Sports Medicine and Orthopedic Center,	Jackson	Mississippi
United States	University of Kansas Medical Centre	Kansas City	Kansas
United States	South Florida Foot and Ankle Center	Lake Worth	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Invibio Ltd	In2Bones

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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