Double Osteotomy for Deformity Correction in Pyle Disease

Double Osteotomy for Deformity Correction In Pyle Disease: Comparative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pyle Disease
• Intervention / Treatment: Procedure: Single osteotomy; Procedure: Double Osteotomy

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherwan Hamawandi, ass. prof.; Phone Number: 009647504464321; Email: sherwan.hamawandi@hmu.edu.krd

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Recruiting
    • Hawler Medical University
    • Contact: Sherwan Hamawandi, ass.Prof.; Phone Number: 009647504464321; Email: sherwan.hamawandi@hmu.edu.krd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pyle Disease

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single tibial osteotomy; Single tibial osteotomy done to achieve correction	Procedure: Single osteotomy; Single tibial osteotomy
Active Comparator: Double tibial osteotomy; Double tibial osteotomy done to achieve correction	Procedure: Double Osteotomy; Double Tibial Osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical axis of lower limbs	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	This mechanical axes were assessed one year after surgery
Knee injury and Osteoarthritis outcome score	This score involves six sections from zero score to 100. The more score is better outcome	This score was assessed one year post-operatively

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2021
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Functional outcome; Pyle disease; Genu valgus; Double Osteotomy; Deformity analysis
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Congenital Abnormalities; Osteochondrodysplasias
• Other Study ID Numbers: HMU/Sherwan14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No