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Evaluation of the use of Bone Grafts in Knee Osteotomy Surgery

Comparative study between Medial Opening Wedge Osteotomy with Autologous versus Homologous Graft

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9kt87y7
Enrollment
Unknown
Registered
2022-12-01
Start date
2020-12-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genu Varum

Interventions

This is a two-arm longitudinal randomized controlled clinical trial. The recruitment enrolled 60 patients, equally randomized into the two study groups. The distribution of participants in the groups
A01.941.500

Sponsors

Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad
Lead Sponsor
Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad
Collaborator

Eligibility

Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Both genders; age between 20 and 60 years; isolated osteoarthritis of the medial compartment of the knee associated with varus deformity; ligament injury with asymmetric varus axis deviation; preserved range of motion, ie at least 90º flexion and less than 10º flexion contracture; conservative treatment failure; ability to read and understand the Free and Informed Consent Term and agreement to participate in the research

Exclusion criteria

Exclusion criteria: Systemic inflammatory diseases; age over 60 or under 20; planned corrections with calculations larger than 17.5 mm or smaller than 10 mm; previous surgeries on the affected knee; previous infections in the affected limb; pain in the lateral or anterior compartments of the affected knee; lateral meniscus injury; severe osteoarthritis of the knee (grades 4 and 5 of the Ahlbäck classification)

Design outcomes

Primary

MeasureTime frame
The healing time of osteotomies is expected to be similar in the groups that were treated with autologous and allogeneic bone grafts, evaluated by the Schröter index, considering that both groups will present values ??equal to or greater than 0.75 (the cutoff point that indicates bone consolidation). Furthermore, it is expected that individuals in the autograft and allograft groups present the same radiological evolution and the presence of sclerosis and the trabecular structure of the osteotomy gap, according to the Van Hemert scale and the criteria defined by Staubli, respectively.

Secondary

MeasureTime frame
The complication rate of osteotomies is expected to be similar in the groups that were treated with autologous and allogeneic bone grafts during the study evaluation period (two years after the procedure), which was analyzed by clinical and radiological records collected in postoperative evaluations, such as the presence of deep or superficial infection, loss of correction, delayed consolidation, pseudarthrosis, failure of the synthesis material and loss of angulation.;It is expected that the surgical time of osteotomy with the use of allogeneic bone graft will be reduced in relation to procedures in which autologous grafts are used, evaluated by recording the time of surgery from ischemia to the beginning of closure, discounting the time of secondary procedures performed concomitantly with osteotomy, such as arthroscopic evaluation, repairs of chondral or meniscus injuries, and the surgical time of tibial plateau fixation in a case associated with a medial meniscus root reinsertion.

Countries

Brazil

Contacts

Public ContactRafael de Paula

Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad

erthalortopedia@gmail.com+55-21-21345000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)