What side effects are associated with this type of intervention?

Common treatments for osteoporosis, such as bisphosphonates (e.g., alendronate, zoledronic acid) and denosumab, have several known side effects. Bisphosphonates can cause gastrointestinal issues, musculoskeletal pain, osteonecrosis of the jaw, and atypical femoral fractures. Intravenous forms may also lead to flu-like symptoms and nephrotoxicity. Denosumab can result in hypocalcemia, infections, and rebound vertebral fractures if discontinued. Monitoring for these adverse effects is essential during treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of osteoporosis, including bisphosphonates like alendronate, zoledronic acid, and risedronate, which are known for their efficacy in reducing fracture risk and maintaining bone density. Additionally, anabolic agents such as teriparatide and romosozumab have been approved for their ability to increase bone mineral density and reduce fracture incidence. These treatments, particularly bisphosphonates, work by inhibiting osteoclast-mediated bone resorption, thereby gradually improving bone strength and integrity, somewhat analogous to the gradual absorption and integration seen with bioabsorbable screws in orthopedic applications.

What other types of research exist?

Promising novel alternatives to bioabsorbable screws for osteoporosis patients include bio-integrative implants, which offer good osteosynthesis, lower rates of removal, and reduced imaging artifacts. These implants are designed to gradually integrate into the bone, providing structural support while minimizing long-term complications.

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Bioabsorbable Implant

Bio-Integrative vs Metallic Screws for Flatfoot Surgery

N/A

Recruiting

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery

Clinical diagnosis of hindfoot malalignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus

Must not have

Osteotomies requiring resection of wedges (Dweyer, triple Dweyer, etc.)

Osteotomies planned to occur in a non-traditional cut (Malerba, Scarf, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests special dissolvable screws in patients having specific foot surgery. The goal is to see if these screws work as well as traditional metal ones for bone healing and other outcomes. The dissolvable screws support the bone during healing and then naturally break down, reducing long-term complications. Bioabsorbable screws have been used in orthopaedic surgery for many years, but their specific indications in foot trauma surgery are still being defined.

Who is the study for?

This trial is for adults aged 18-75 with hindfoot malalignment, experiencing symptoms for at least six months. Candidates must be planning a calcaneus osteotomy using an oblique cut. Exclusions include inability to consent, infections in the treatment area, previous surgery on the affected foot, neuropathy or systemic inflammatory diseases.

What is being tested?

The study compares bio-integrative screws versus metallic screws in foot surgeries (calcaneus osteotomies). It aims to evaluate if bioabsorbable screws can match metallic ones in clinical and radiographical outcomes post-surgery.

What are the potential side effects?

While not explicitly listed, potential side effects may include typical surgical risks such as infection, pain at the implant site, inflammation around the screw area, and possible adverse reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had symptoms from my condition for at least 6 months before my surgery.

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My foot is misaligned, either angled outward more than 10 degrees or any inward angle.

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I am between 19 and 74 years old.

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I am scheduled for a specific foot surgery involving a bone cut.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to correct bone deformities.

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My surgery involves special bone cuts.

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I have a history of nerve issues or inflammatory diseases like rheumatoid arthritis.

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I am unable to sign the consent form.

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I have had surgery on my heel bone before.

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I have a history of autoimmune or peripheral vascular diseases.

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I have an infection in the area that needs treatment.

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I don't have any health issues that prevent me from receiving the proposed treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone healing

Secondary study objectives

Complications

Implant-related artifact

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bio-integrativeExperimental Treatment1 Intervention

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.

Group II: MetallicActive Control1 Intervention

Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoporosis include bisphosphonates, denosumab, and anabolic agents like teriparatide. Bisphosphonates work by inhibiting osteoclast-mediated bone resorption, thereby maintaining bone density. Denosumab is a monoclonal antibody that also inhibits osteoclasts, reducing bone resorption. Anabolic agents like teriparatide stimulate bone formation by activating osteoblasts. These mechanisms are crucial for osteoporosis patients as they help increase bone strength and reduce fracture risk. Similar to bioabsorbable screws that gradually integrate into bone, these treatments aim to improve bone health over time, providing long-term benefits.

Percutaneous cement augmentation for osteoporotic vertebral fractures.