Double Osteotomy for Deformity Correction in Pyle Disease

Not Applicable

• Conditions: Pyle Disease
• Interventions: Procedure: Double Osteotomy; Procedure: Single osteotomy

• Registration Number: NCT05046977
• Lead Sponsor: Hawler Medical University

Brief Summary

Leg deformity is one of the features of Pyle disease( metaphyseal dysplasia). Correction of valgus deformity of the leg can be done after deformity analysis by double osteotomy so this study showed how double osteotomy can lead to better results than single osteotomy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Study Start: 2021-09-20
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Pyle Disease

Exclusion Criteria

1. Smoking
2. Diabets Mellitus
3. Previous surgery on the limbs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double tibial osteotomy	Double Osteotomy	Double tibial osteotomy done to achieve correction
Single tibial osteotomy	Single osteotomy	Single tibial osteotomy done to achieve correction

Primary Outcome Measures

Name	Time	Method
Mechanical axis of lower limbs	This mechanical axes were assessed one year after surgery	This will determine how much the mechanical axes of the lower limbs were diverted from the normal values. We asked for lower limb radiograph in both Anteroposterior and lateral views and we measure the mechanical axes of the whole lower limb and that of tibial and measures how much the proximal medial tibial angle and compared with normal values
Knee injury and Osteoarthritis outcome score	This score was assessed one year post-operatively	This score involves six sections from zero score to 100. The more score is better outcome

Trial Locations

Locations (1)

Hawler medical University; 🇮🇶 Erbil, Iraq