An interventional study of osteotomy in Deformity Knee and Deformity of Limb, sponsored by Tanta University. Completed. Open to participants aged 36 Months to 52 Months. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum
Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.
20 studies on the registry are indexed under Genu Varum; 9 are open to participants now.
This study's enrollment of 70 is above the median of 56 across 14 interventional studies indexed under Genu Varum.
Browse Genu Varum studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion criteria:
Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.
Procedure: osteotomy
osteotomy osteoclasis of upper tibia
proximal medial tibial angle
This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction
Time frame: one year
the posterior proximal tibial angle
confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)
Time frame: one year
Self-Administered Patient Satisfaction Scale
the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, \<75 to 50 somewhat satisfied, \<50 to 25 somewhat dissatisfied and \<25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.
Time frame: one year
No study locations are listed for this record.
Plan to share: No — the investigators will publish the final results
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Tanta University