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Synthetic Cartilage Implant vs. Arthroplasty for Hallux Rigidus
Study Summary
This trial will compare two different surgical treatments for grade III hallux rigidus. One group will have a synthetic cartilage implant inserted at the MTP joint, while the second group will have a dermal interposition arthroplasty. Pain, complications, and functional results will be evaluated after two years.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You want or need to have surgery to fuse the big toe joint in your foot.You have a history of autoimmune diseases or diseases related to the blood vessels in your arms or legs.You have an infection in the area where the treatment will be done, either on the skin or deep inside the bone.You have severe stiffness or immobility in your big toe joint.You have previously had surgery to fuse the big toe joint.You have a history of nerve problems or certain inflammatory diseases like arthritis.You have a medical condition that makes the proposed treatments unsafe for you.You have been clinically diagnosed with a condition called hallux rigidus, which affects your big toe joint.You have a medical reason or strong desire to undergo a different type of surgery.You have been diagnosed with untreated osteoporosis based on medical tests and scans.You have limited movement in your big toe joint (less than 20 degrees).You cannot feel your pulse in the front or back of your lower leg, or your capillary filling test results are abnormal.
- Group 1: Synthetic Cartilage Implant
- Group 2: Dermal Interposition Arthroplasty
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the minimum age threshold for this research trial under 40 years old?
"Individuals aged between 18 and 75 are eligible to take part in this clinical study. Moreover, two dedicated studies exist for patients younger than 18 years old while 6 additional ones focus on seniors over 65 of age."
Is this clinical trial accepting enrollment at the present time?
"Affirmative. The data found on clinicaltrials.gov corroborates that this medical trial, which was initially posted to the site on July 5th 2022 is actively seeking participants. Roughly 100 individuals must be recruited from a single location for this research project to proceed."
What is the maximum number of participants accepted into this experiment?
"Affirmative. According to clinicaltrials.gov, this research effort is actively enrolling participants; the trial was initially posted on July 5th 2022 and last modified on September 29th 2022. The study aims to recruit 100 individuals from one single site of enrollment."
Who would be the ideal candidates for inclusion in this investigation?
"To qualify for this medical trial, applicants must have hallux rigidus and be aged 18 to 75. The team behind the experiment is in need of 100 total participants."
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