Hallux RigidusNCT05692687
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
An observational study of Hallux Rigidus, run by Invibio Ltd at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Rigidus
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2023to 12 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective study so patients taken from those undergoing treatment surgery for Hallux Rigidus.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mississippi Sports Medicine and Orthopedic Center,
Jackson, Mississippi, 39202
University of Kansas Medical Centre
Kansas City, Kansas, 66160
South Florida Foot and Ankle Center
Lake Worth, Florida, 33462
About this study
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
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
- Medical subject headings
- Hallux Rigidus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Mar 2023
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invibio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- In2Bones
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692687
- Sponsor's protocol ID
- IN2B01
- Status last verified
- Nov 2025
- First submitted
- 11 Jan 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05692687
- Acronym / sponsor ID
- IN2B01
- Conditions
- Hallux Rigidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Invibio LtdIndustry (pharma, biotech, devices)
- Collaborators
- In2Bones
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective study so patients taken from those undergoing treatment surgery for Hallux Rigidus.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Fusion
Time frame: 6 months
Successful radiographic union: where union is defined as 'evidence of bridging' between the metatarsal bone and proximal phalanx bone by an independent imaging company.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hallux Rigidus
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Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
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Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Rigidus, run by Invibio Ltd at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Fusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.