Back to resultsDouble Osteotomy for Deformity Correction in Pyle Disease
Primary Purpose
Pyle Disease
Status
Unknown status
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Single osteotomy
Double Osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Pyle Disease focused on measuring Pyle disease, Genu valgus, Double Osteotomy, Deformity analysis, Functional outcome
Eligibility Criteria
Inclusion Criteria:
- Pyle Disease
Exclusion Criteria:
- Smoking
- Diabets Mellitus
- Previous surgery on the limbs
Sites / Locations
- Hawler medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single tibial osteotomy
Double tibial osteotomy
Arm Description
Single tibial osteotomy done to achieve correction
Double tibial osteotomy done to achieve correction
Outcomes
Primary Outcome Measures
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
Knee injury and Osteoarthritis outcome score
This score involves six sections from zero score to 100. The more score is better outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05046977
First Posted
September 12, 2021
Last Updated
September 13, 2021
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05046977
Brief Title
Double Osteotomy for Deformity Correction in Pyle Disease
Official Title
Double Osteotomy for Deformity Correction In Pyle Disease: Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
September 20, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyle Disease
Keywords
Pyle disease, Genu valgus, Double Osteotomy, Deformity analysis, Functional outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single tibial osteotomy
Arm Type
Active Comparator
Arm Description
Single tibial osteotomy done to achieve correction
Arm Title
Double tibial osteotomy
Arm Type
Active Comparator
Arm Description
Double tibial osteotomy done to achieve correction
Intervention Type
Procedure
Intervention Name(s)
Single osteotomy
Intervention Description
Single tibial osteotomy
Intervention Type
Procedure
Intervention Name(s)
Double Osteotomy
Intervention Description
Double Tibial Osteotomy
Primary Outcome Measure Information:
Title
Mechanical axis of lower limbs
Description
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
Time Frame
This mechanical axes were assessed one year after surgery
Title
Knee injury and Osteoarthritis outcome score
Description
This score involves six sections from zero score to 100. The more score is better outcome
Time Frame
This score was assessed one year post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pyle Disease
Exclusion Criteria:
Smoking
Diabets Mellitus
Previous surgery on the limbs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherwan Hamawandi, ass. prof.
Phone
009647504464321
Email
sherwan.hamawandi@hmu.edu.krd
Facility Information:
Facility Name
Hawler medical University
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherwan Hamawandi, ass.Prof.
Phone
009647504464321
Email
sherwan.hamawandi@hmu.edu.krd
12. IPD Sharing Statement
Learn more about this trial
Double Osteotomy for Deformity Correction in Pyle Disease
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