DiaphysesPhase 1NCT02338258
The Study of the Nonunion of Long Tubular Bone
A Phase 1 study testing Anti-rotational plate and Exchanged Intramedullary nailing in people with Diaphyses, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphyses
- What is being tested?
- Anti-rotational plate and Exchanged Intramedullary nailing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2017
- Phase
- Phase 1
- 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 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The patient who had the nonunion of long tubular bone
- The patient who was the age of 14 ~ 65 years old.
- The patient who complete the follow-up conditions.
- The patient who has independent behavior ability.
- The patient who volunteered for signed informed consent
Who cannot join
- Infectious nonunion of the long turubar bone
- Pathological fracture.
- The immune system disease.
- Cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The orthopaedic Trauma center of Jishuitan Hospital in Beijing
Beijing, Beijing Municipality, 730000
xianzhi XZ Ma, MD, +8615201542942, 870248900@qq.com
About this study
Official title: The Prospective、Randomized、Comparative Clinical Study About the Two Operation Methods Between Anti-rotational Plate Group and Exchanged Intramedullary Nailgroup to Treat the Nonunion of Long Tubular Bone After Intramedullary Nail Fixation
The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing
- Conditions
- Diaphyses
- Being tested
- Anti-rotational plate, Exchanged Intramedullary nailing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-rotational plateDevice
Exchanged Intramedullary nailingDevice
| Study group | Role | What they receive |
|---|---|---|
| The Anti-rotational plate group | Experimental | The method was used to control the rotational unstabilization at the fracture site Receives: Device: Anti-rotational plate; Device: Exchanged Intramedullary nailing |
| Exchanged Intramedullary nailing group | Placebo comparator | the method Provided the axial and rotational stability Receives: Device: Exchanged Intramedullary nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The healing rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiaphysesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianzhi Ma, Beijing Jishuitan Hospital
- Investigators
- Bosong Zhang, MD, Principal investigator, Jishuitan hospital in Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338258
- Sponsor's protocol ID
- Z141107002514086
- Status last verified
- Jan 2015
- First submitted
- 26 Dec 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective、Randomized、Comparative Clinical Study About the Two Operation Methods Between Anti-rotational Plate Group and Exchanged Intramedullary Nailgroup to Treat the Nonunion of Long Tubular Bone After Intramedullary Nail Fixation
- ClinicalTrials.gov ID
- NCT02338258
- Acronym / sponsor ID
- Z141107002514086
- Conditions
- Diaphyses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Jan 2015 (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 the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Anti-rotational plate group | Experimental | Device: Anti-rotational plate, Device: Exchanged Intramedullary nailingThe method was used to control the rotational unstabilization at the fracture site |
| Exchanged Intramedullary nailing group | Placebo comparator | Device: Exchanged Intramedullary nailingthe method Provided the axial and rotational stability |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The patient who had the nonunion of long tubular bone
- The patient who was the age of 14 ~ 65 years old.
- The patient who complete the follow-up conditions.
- The patient who has independent behavior ability.
- The patient who volunteered for signed informed consent
Key exclusion criteria (4 listed)
- Infectious nonunion of the long turubar bone
- Pathological fracture.
- The immune system disease.
- Cancer
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 |
|---|---|---|
| Anti-rotational plate | Device | The Anti-rotational plate group |
| Exchanged Intramedullary nailing | Device | Exchanged Intramedullary nailing group, The Anti-rotational plate group |
Primary outcome
The healing rate
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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.
Bosong Zhang, MD principal investigator
Jishuitan hospital in Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-rotational plate and Exchanged Intramedullary nailing in people with Diaphyses, run by Beijing Jishuitan Hospital at 1 site 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 5 inclusion and 4 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 14 Jan 2015. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bosong BS zhang, MD (+8613621219567 ext. +86, zhangbosong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healing rate (time frame: 9 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 14 Jan 2015.