An interventional study of Calcaneus Osteotomy (Metallic) and Calcaneus Osteotomy (Bio-integrative) in Flatfoot, Bone Resorption and Cavus Deformity, sponsored by University of Iowa. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
The use of bio-integrative implants in orthopedic surgery is growing exponentially. As many biomechanical and histological studies were able to sustain its structural and biological properties, few clinical studies are available to support its advantages, such as good osteosynthesis, lower rates of removal, and diminished implant-related artifact in imaging studies. This information is vital to providers when choosing the proper material and planning postoperative treatment. This trial intends to test the capacity of the bioabsorbable screws in reaching the same clinical and radiographical outcomes of the current metallic screws.
A minimum of 44 patients undergoing Medial or Lateral Displacement Calcaneal Osteotomy (MDCO) will be randomized in two parallel groups for surgery, considering applied the implant. One group will be operated using two 4.0mm cannulated bio-integrative (absorbable) screws, and the other group using two 4.0mm cannulated metallic screws. Patients will be blinded evaluated for a mean follow-up of twelve weeks in terms of bone healing, complications, and implant-related artifact using weight-bearing computed tomography (WBCT).
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 44 is close to the median of 40 across 122 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm bio-integrative cannulated screws.
Procedure: Calcaneus Osteotomy (Bio-integrative)
Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.
Procedure: Calcaneus Osteotomy (Metallic)
Calcaneus Displacement Osteotomy using two metallic screws
Calcaneus Displacement Osteotomy using two bio-integrative screws
Bone healing
- Amount of bone bridging crossing the osteotomy site: Determined by the percentage of bone trabeculae crossing the osteotomy site on every tomography cut (amount of the cut in millimeters that shows bone spanning the two fragments divided by the total amount of osteotomy's surface on the cut). - Weight-bearing computed tomography (WBCT) acquisitions will be used to determine this percentage.
Time frame: 6 weeks
Complications
- Percentage of minor and major complications: Dehiscence: inability to heal the soft tissue coverage until the end of the 4th post-operative week. Peripherical nerve damage: hypoesthesia or paresthesia not solved until the 6th week after the surgery. Infection: clinical signs of site infection or pus drainage at the wound that required antibiotics.
Time frame: 6 weeks
Implant-related artifact
- Quantity of Hounsfield units around the implants Measured on WBCT acquisitions.
Time frame: 6 weeks
Plan to share: Yes — Nonidentified data will be shared to researchers upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After the study's publication and for 10 years.
Access criteria: Reasonable request.
Started Nov 2021 (actual). Primary completion is estimated for Jul 2024, 32 months after the start.
Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 32 months is above that.
Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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