Bone DiseasesNCT03129230
Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
A study testing free nonvascularized fibula autograft in people with Bone Diseases, run by Yulin Orthopedics Hospital of Chinese and Western Medicine at 2 sites in China.
Trial summary
This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Bone Diseases
- What is being tested?
- free nonvascularized fibula autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2012to 1 Mar 2017
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.
Who cannot join
- pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;
- pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;
- adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yulin Orthopedics Hospital of Chinese and Western Medicine
Yulin, Guangxi
About this study
Official title: Yulin Orthopedics Hospital of Chinese and Western Medicine
This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications.
- Conditions
- Bone Diseases
- Being tested
- free nonvascularized fibula autograft
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free nonvascularized fibula autograftProcedure or surgery
Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections.
| Study group | Role | What they receive |
|---|---|---|
| Free nonvascularized fibula autograft | Experimental | Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck. Receives: Procedure: free nonvascularized fibula autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of peri-implant bone level from baseline at 7 and 54 months
Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months.
Measured: 7 months to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Aug 2012
- Primary completion1 Sep 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yulin Orthopedics Hospital of Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanchao Luo, Yulin Orthopedics Hospital of Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129230
- Sponsor's protocol ID
- 20170301c
- Status last verified
- Nov 2018
- First submitted
- 5 Apr 2017
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yulin Orthopedics Hospital of Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT03129230
- Acronym / sponsor ID
- 20170301c
- Conditions
- Bone Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yulin Orthopedics Hospital of Chinese and Western MedicineUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 26 Apr 2017 (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.
This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Free nonvascularized fibula autograft | Experimental | Procedure: free nonvascularized fibula autograftSixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.
Key exclusion criteria (3 listed)
- pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;
- pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;
- adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.
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 |
|---|---|---|
| free nonvascularized fibula autograftSixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections. | Procedure or surgery | Free nonvascularized fibula autograft |
Primary outcome
change of peri-implant bone level from baseline at 7 and 54 months
Time frame: 7 months to 54 months
Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months.
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 27 Nov 2018.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free nonvascularized fibula autograft in people with Bone Diseases, run by Yulin Orthopedics Hospital of Chinese and Western Medicine at 2 sites in China.
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: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
change of peri-implant bone level from baseline at 7 and 54 months (time frame: 7 months to 54 months). 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 27 Nov 2018.