SHOX Gene With Short StatureNCT01328418
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
A study testing Lengthening over nail in people with SHOX Gene With Short Stature, run by Bilen, Fikri Erkal, M.D. at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- SHOX Gene With Short Stature
- What is being tested?
- Lengthening over nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2002to Mar 2011
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Achondroplasia, first lengthening period
Who cannot join
- Previous lengthening
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.
- Conditions
- SHOX Gene With Short Stature
- Being tested
- Lengthening over nail
- Keywords
- Lengthening
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lengthening over nailProcedure or surgery
External fixator is used to lengthen either the femur or the tibia over an intramedullary nail
| Study group | Role | What they receive |
|---|---|---|
| Achondroplasia lengthening | Other | Not described Receives: Procedure: Lengthening over nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paley's functional scoring system
Paley's functional scoring system evaluates the results after lengthening or deformity correction procedures: residual limb length discrepancy, any brace or other aid usage, joint contracture, pain, soft tissue dystrophism
Measured: Minimum 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startApr 2002
- Primary completionMar 2008
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SHOX Gene With Short StatureStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilen, Fikri Erkal, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328418
- Sponsor's protocol ID
- Akondroplazi - Bilen
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
- ClinicalTrials.gov ID
- NCT01328418
- Acronym / sponsor ID
- Akondroplazi - Bilen
- Conditions
- SHOX Gene With Short Stature
- Keywords
- Lengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bilen, Fikri Erkal, M.D.
- Study start
- Apr 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Apr 2011 (estimated)
- 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.
The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achondroplasia lengthening | Other | Procedure: Lengthening over nail |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Achondroplasia, first lengthening period
Key exclusion criteria (1 listed)
- Previous lengthening
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 |
|---|---|---|
| Lengthening over nailExternal fixator is used to lengthen either the femur or the tibia over an intramedullary nail | Procedure or surgery | Achondroplasia lengthening |
Primary outcome
Paley's functional scoring system
Time frame: Minimum 2 year follow-up
Paley's functional scoring system evaluates the results after lengthening or deformity correction procedures: residual limb length discrepancy, any brace or other aid usage, joint contracture, pain, soft tissue dystrophism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
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A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
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Enrolling by invitationObservational study
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A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lengthening over nail in people with SHOX Gene With Short Stature, run by Bilen, Fikri Erkal, M.D. at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 4 Apr 2011. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paley's functional scoring system (time frame: Minimum 2 year follow-up). 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 4 Apr 2011.