TIBIA PSEUDOARTHROSESNCT01246934
Segment Transport Versus Acute Shortening In The Treatment of Tibial Pseudarthroses With Bone Loss
A study testing ASR METHOD in people with TIBIA PSEUDOARTHROSES, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In this study the investigators are presenting the advantages as well as the disadvantages of ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- TIBIA PSEUDOARTHROSES
- What is being tested?
- ASR METHOD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2009to Feb 2010
- 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 13 to 50 years
- All sexes
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators are presenting the advantages as well as the disadvantages of ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.
- Conditions
- TIBIA PSEUDOARTHROSES
- Being tested
- ASR METHOD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASR METHODOther
| Study group | Role | What they receive |
|---|---|---|
| COMPLICATION | No intervention | Not described Receives: Other: ASR METHOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
TREATMENT PERIOD AND COMPLICATION RATE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TIBIA PSEUDOARTHROSESStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246934
- Sponsor's protocol ID
- BVUORT001
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Paley D, Sen C, Tetsworth K. Acute Shortening With Subsequent Relengthening Versus Bone Transport In The Treatment Of Tibial Bone Defect, 11th Asami North America Annual Scientific Meeting, February 18-25, Berkeley Ca, 2001
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segment Transport Versus Acute Shortening In The Treatment of Tibial Pseudarthroses With Bone Loss
- ClinicalTrials.gov ID
- NCT01246934
- Acronym / sponsor ID
- BVUORT001
- Conditions
- TIBIA PSEUDOARTHROSES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Nov 2010 (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.
In this study the investigators are presenting the advantages as well as the disadvantages of ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMPLICATION | No intervention | Other: ASR METHOD |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ASR METHOD | Other | COMPLICATION |
Primary outcome
TREATMENT PERIOD AND COMPLICATION RATE
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 24 Nov 2010.
- Results publicationPaley D, Sen C, Tetsworth K. Acute Shortening With Subsequent Relengthening Versus Bone Transport In The Treatment Of Tibial Bone Defect, 11th Asami North America Annual Scientific Meeting, February 18-25, Berkeley Ca, 2001
Related trials for TIBIA PSEUDOARTHROSES
RecruitingPhase 3
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Congenital Pseudarthrosis of Tibia
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 ASR METHOD in people with TIBIA PSEUDOARTHROSES, run by Bezmialem Vakif University 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 0 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 24 Nov 2010. 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?
TREATMENT PERIOD AND COMPLICATION RATE. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246934, which also lists 1 linked publication.
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 24 Nov 2010.