New carbon fiber plate offers hope for stiff big toe sufferers
NCT ID NCT05692687
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tested a special carbon fiber plate and screws to treat hallux rigidus, a condition that causes stiffness and pain in the big toe joint. 18 adults who needed surgery for this condition took part. The surgery removed damaged cartilage and fused the bones together using the plate. The main goal was to see if the bones healed properly.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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18 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Prospective study so patients taken from those undergoing treatment surgery for Hallux Rigidus.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mississippi Sports Medicine and Orthopedic Center,
Jackson, Mississippi, 39202, United States
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South Florida Foot and Ankle Center
Lake Worth, Florida, 33462, United States
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University of Kansas Medical Centre
Kansas City, Kansas, 66160, United States
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