Pyle DiseaseNCT05046977
Double Osteotomy for Deformity Correction in Pyle Disease
A study testing Single osteotomy and Double Osteotomy in people with Pyle Disease, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pyle Disease
- What is being tested?
- Single osteotomy and Double Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIraq
- Study dates
- 20 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pyle Disease
Who cannot join
- Smoking
- Diabets Mellitus
- Previous surgery on the limbs
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Hawler medical University
Erbil, 44001
Sherwan Hamawandi, ass.Prof., 009647504464321, sherwan.hamawandi@hmu.edu.krd
About this study
Official title: 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.
- Conditions
- Pyle Disease
- Being tested
- Single osteotomy, Double Osteotomy
- Keywords
- Pyle disease, Genu valgus, Double Osteotomy, Deformity analysis, Functional outcome
- Medical subject headings
- Pyle disease, Genu Valgum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single osteotomyProcedure or surgery
Single tibial osteotomy
Double OsteotomyProcedure or surgery
Double Tibial Osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Single tibial osteotomy | Active comparator | Single tibial osteotomy done to achieve correction Receives: Procedure: Single osteotomy |
| Double tibial osteotomy | Active comparator | Double tibial osteotomy done to achieve correction Receives: Procedure: Double Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: This score was assessed one year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyle DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046977
- Sponsor's protocol ID
- HMU/Sherwan14
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Osteotomy for Deformity Correction In Pyle Disease: Comparative Study
- ClinicalTrials.gov ID
- NCT05046977
- Acronym / sponsor ID
- HMU/Sherwan14
- Conditions
- Pyle Disease
- Keywords
- Pyle disease, Genu valgus, Double Osteotomy, Deformity analysis, Functional outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single tibial osteotomy | Active comparator | Procedure: Single osteotomySingle tibial osteotomy done to achieve correction |
| Double tibial osteotomy | Active comparator | Procedure: Double OsteotomyDouble tibial osteotomy done to achieve correction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pyle Disease
Key exclusion criteria (3 listed)
- Smoking
- Diabets Mellitus
- Previous surgery on the limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single osteotomySingle tibial osteotomy | Procedure or surgery | Single tibial osteotomy |
| Double OsteotomyDouble Tibial Osteotomy | Procedure or surgery | Double tibial osteotomy |
Primary outcome
Mechanical axis of lower limbs
Time frame: 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
Time frame: This score was assessed one year post-operatively
This score involves six sections from zero score to 100. The more score is better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Related trials for Pyle Disease
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single osteotomy and Double Osteotomy in people with Pyle Disease, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherwan Hamawandi, ass. prof. (009647504464321, sherwan.hamawandi@hmu.edu.krd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical axis of lower limbs (time frame: This mechanical axes were assessed one year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.