Calcaneus Osteotomy (Bio-integrative) for Bone Resorption

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine, Iowa City, IA
Bone Resorption+5 More
Calcaneus Osteotomy (Bio-integrative) - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether bioabsorbable screws are as effective as metallic screws in orthopedic surgery.

See full description

Eligible Conditions

  • Bone Resorption
  • Cavus Deformity
  • Complications
  • Flatfoot
  • Osteolysis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Calcaneus Osteotomy (Bio-integrative) will improve 1 primary outcome and 2 secondary outcomes in patients with Bone Resorption. Measurement will happen over the course of 6 weeks.

6 weeks
Bone healing
Complications
Implant-related artifact

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Metallic
1 of 2
Bio-integrative
1 of 2
Active Control
Experimental Treatment

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Calcaneus Osteotomy (Bio-integrative) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks for reporting.

Who is running the study

Principal Investigator
C. D. C. N.
Prof. Cesar De Cesar Netto, Assistant Professor
University of Iowa

Closest Location

Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals must be older than 18 and younger than 75 years of age, both genders;
Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery;
Clinical diagnosis of hindfoot malignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus;
Surgical planning, including a calcaneus displacement osteotomy through a traditional oblique cut.

Patient Q&A Section

What are the signs of osteolysis?

"Symptoms of osteolysis that may be experienced include joint pain and stiffness, loss of bone mass, and possible joint deformity. Patients often undergo X-rays to rule out osteolytic lesions, and may be tested for low levels of calcium or vitamin D." - Anonymous Online Contributor

Unverified Answer

What is osteolysis?

"In summary, this is the first study to describe spontaneous subperiosteal ossification in a human non-traumatic OA. The subperiosteal ossification appears not as a result of bone resorption or bone formation and is more likely the result of bone resorption which is a response to localized mechanical stress during physical activities." - Anonymous Online Contributor

Unverified Answer

What causes osteolysis?

"The cause of osteolysis is multifactorial. The primary mechanism is probably cytokine-mediated tissue destruction with further involvement of osteoclasts. The exact mechanism underlying this destructive process is still not totally known and further study is needed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for osteolysis?

"The most common treatments for osteolysis include non-steroidal anti-inflammatory medications (e.g. aspirin, Ibuprofen), corticosteroids, orthopaedic surgery, and physical therapy. Most treatments involve an interdisciplinary approach." - Anonymous Online Contributor

Unverified Answer

How many people get osteolysis a year in the United States?

"Achieving a definitive definition of osteolysis requires the application of stringent definitions; no studies of this nature have previously assessed this issue. Of the 11 studies that are included in the literature, none are based on data derived in clinical practice. However, one study was based on self-reported case definitions drawn from the literature. Results from a recent paper of this study indicate that osteolysis may be more widespread than previously thought and it is possible that the prevalence of this condition increases with age." - Anonymous Online Contributor

Unverified Answer

Can osteolysis be cured?

"Osteolysis can be cured. Patients can therefore feel confident that it will not recur if there is the usual, periodic follow-up. However, in order to prevent recurrence new symptoms must be noticed when bone remodelling has occurred." - Anonymous Online Contributor

Unverified Answer

What does calcaneus osteotomy (bio-integrative) usually treat?

"Based on these data it is hard to draw clear conclusions about this kind of procedure. Most of these articles were found by searching on web sites and some other searches like PubMed. However, according to a search the author found the most of the studies (about 21%) were published in “Western” countries. It is possible there could be a higher chance for b-ie-nj-o-t-o-s-is procedure to be considered for American patients, but it should be proven with more numbers of trials." - Anonymous Online Contributor

Unverified Answer

Is calcaneus osteotomy (bio-integrative) safe for people?

"The findings of this study suggest that calcaneus osteotomy is a safe procedure, providing the necessary time for restoration of bone mass before surgery. Additional randomized trials are warranted to definitively assess the efficacy of this surgical intervention for the management of non-traumatic femoral neck fractures." - Anonymous Online Contributor

Unverified Answer

What is calcaneus osteotomy (bio-integrative)?

"calcaneus osteotomy with integrative foot and ankle surgery is an effective method of improving foot function and relieving [metatarsalgia] as part of an overall treatment program." - Anonymous Online Contributor

Unverified Answer

What is the latest research for osteolysis?

"The use of a low-speed, oscillating air turbine was safer than conventional ultrasound, but the magnitude of osteolysis was similar. The use of conventional ultrasound did not result in improved mechanical properties compared to conventional ultrasonography. [NCT00918095]." - Anonymous Online Contributor

Unverified Answer

Is calcaneus osteotomy (bio-integrative) typically used in combination with any other treatments?

"As the sample size is small, further study is needed to identify if the combination of bone grafting and calcaneus osteotomy is better than just using osteotomy alone. The indications might also change with an increasing number of cases. Results from a recent clinical trial emphasizes the need for standardized studies to identify effective treatments for CMT." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in calcaneus osteotomy (bio-integrative) for therapeutic use?

"The application of bi-integrative (calcaneal osteotomy) calcaneal osteotomy is a valid treatment for the treatment of painful and severe osteoarthritic degeneration of the calcaneal spur in a diabetic patient with a high risk of amputation. This treatment is an adjunctive treatment approach, and has shown significant functional effect." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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