Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial
NCT ID: NCT05518721
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-07-05
2023-12-14
Brief Summary
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Detailed Description
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The synthetic implant begins by performing and dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally, osteophytes removed, and a guidewire inserted through the center of the first metatarsal head. The position of the metallic wire is checked and the tunnel for the implant is drilled. The synthetic cartilage implant (Cartiva™, Stryker Medical®) is introduced through the tunnel, leaving it proud with the head surface by 2mm. The capsule is closed, followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The interposition arthroplasty initiates with the same dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally and osteophytes are removed. A guidewire inserted through the center of the first metatarsal head and the center of the proximal phalanx for proper surface preparation. Convex-concaves anatomical drills are used, removing remaining cartilage and opening space for the graft. A decellularized dermal allograft (Arthroflex™, Arthrex®) is placed at the joint and sutured to the head, maintaining the epidermal surface in contact with the phalanx. The graft is trimmed, the capsule is closed, which is followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The WBCT is the standard of care for the preoperative and postoperative assessment of patients with hallux rigidus. Some of the complications will also be evaluated through WBCT. No extra WBCT will be performed other than what we normally do for patients.
Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Synthetic Cartilage Implant
Hallux Rigidus Treatment
Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty
Dermal Interposition Arthroplasty
Hallux Rigidus Treatment
Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty
Interventions
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Hallux Rigidus Treatment
Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty
Eligibility Criteria
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Inclusion Criteria
* Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
* Clinical and radiographical clinical diagnosis of hallux rigidus.
* Hallux Rigidus grade III or grade IV.
* Surgical indication after failure of nonoperative treatment (at least six months).
Exclusion Criteria
* Less than 20 degrees of complete range of motion on the hallux metatarsophalangeal joint.
* Patient desire or medical indication for a hallux metatarsophalangeal joint arthrodesis.
* Patient desire or medical indication for other surgical modalities.
* History or documented evidence of autoimmune or peripheral vascular diseases.
* History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.).
* Any condition that represents a contraindication of the proposed therapies.
* Any physical or social limitation that makes the protocol continuation unviable.
* Impossibility or incapacity to sign the informed Consent Form.
* Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
* Pregnancy.
* Clinical and imaging diagnosis of untreated osteoporosis.
* Serum vitamin D levels below 20ng/ml.
* Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling.
* Tumor lesions (primary or secondary tumors).
18 Years
75 Years
ALL
No
Sponsors
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John Femino
OTHER
Responsible Party
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John Femino
Principal Investigator
Principal Investigators
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John Femino, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Countries
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Other Identifiers
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202010411
Identifier Type: -
Identifier Source: org_study_id