Double Osteotomy for Deformity Correction in Pyle Disease

• Sponsor: Hawler Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05046977
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pyle Disease	Procedure: Single osteotomy; Procedure: Double Osteotomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Double Osteotomy for Deformity Correction In Pyle Disease: Comparative Study
• Anticipated Study Start Date: Sep 20, 2021
• Anticipated Primary Completion Date: Sep 20, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pyle Disease

Exclusion Criteria:

1. Smoking

2. Diabets Mellitus

3. Previous surgery on the limbs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hawler medical University	Erbil		Iraq	44001

Sponsors and Collaborators

• Hawler Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherwan Ahmed Ali Hamawandi, Assistant professor of orthopedic surgery, Hawler Medical University
• ClinicalTrials.gov Identifier: NCT05046977
• Other Study ID Numbers: HMU/Sherwan14
• First Posted: Sep 16, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sherwan Ahmed Ali Hamawandi, Assistant professor of orthopedic surgery, Hawler Medical University: Pyle disease; Genu valgus; Double Osteotomy; Deformity analysis; Functional outcome
• Additional relevant MeSH terms: Osteochondrodysplasias; Congenital Abnormalities

Study Results

No Results Posted as of Sep 16, 2021