Limb Length DiscrepancyNCT04367753
Predictive Factors for the Results of Epiphysiodesis in Limb Length Discrepancy
An observational study of Limb Length Discrepancy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery. The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Limb Length Discrepancy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All minors with limb length discrepancy who had epiphysiodesis surgery
Who may be able to join
- Patients with limb length discrepancy who had epiphysiodesis surgery
Who cannot join
- Missing x-rays
- missing data
- bone growth not achieved
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Hopitâl d'Enfants
Nancy, Lorraine, 54000
Mathias KIRSCH, 0782931465, mathias.kirsch@hotmail.fr
About this study
Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery.
The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care.
The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.
- Conditions
- Limb Length Discrepancy
- Keywords
- Epiphysiodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fulfilled contract | The contract before the epiphysiodesis has been fulfilled with the wanted limb length at the final analysis | |
| Failed contract | The contract before the epiphysiodesis hasn't been fulfilled with the wanted limb length at the final analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb length discrepancy before surgery
Measured: 3 months
Bones length
Measured: 3 months
Predictive bone growth
Measured: 3 months
Time limit between consultation and surgery
Measured: 3 months
Screw position in physis
Measured: 3 months
Bone age at the time of surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Length DiscrepancyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias KIRSCH, Principal investigator, CHU Hôpital d'Enfants Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367753
- Sponsor's protocol ID
- 202PI078
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for the Results of Epiphysiodesis in Limb Length Discrepancy
- ClinicalTrials.gov ID
- NCT04367753
- Acronym / sponsor ID
- 202PI078
- Conditions
- Limb Length Discrepancy
- Keywords
- Epiphysiodesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 29 Apr 2020 (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.
Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery.
The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care.
The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulfilled contract | – | –The contract before the epiphysiodesis has been fulfilled with the wanted limb length at the final analysis |
| Failed contract | – | –The contract before the epiphysiodesis hasn't been fulfilled with the wanted limb length at the final analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All minors with limb length discrepancy who had epiphysiodesis surgery
Key inclusion criteria (1 listed)
- Patients with limb length discrepancy who had epiphysiodesis surgery
Key exclusion criteria (3 listed)
- Missing x-rays
- missing data
- bone growth not achieved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Limb length discrepancy before surgery
Time frame: 3 months
Bones length
Time frame: 3 months
Predictive bone growth
Time frame: 3 months
Time limit between consultation and surgery
Time frame: 3 months
Screw position in physis
Time frame: 3 months
Bone age at the time of surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mathias KIRSCH principal investigator
CHU Hôpital d'Enfants Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Length Discrepancy, run by Central Hospital, Nancy, France at 1 site in France.
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 29 Apr 2020. 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 France. 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 Pierre Journeau (0683177822, p.journeau@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb length discrepancy before surgery (time frame: 3 months). The study lists 6 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 29 Apr 2020.