Periprosthetic FracturesNCT03358186
Investigation on the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty
An observational study of Periprosthetic Fractures, run by Peking University People's Hospital.
Trial summary
To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip Arthroplasty Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Periprosthetic Fractures
- What is being tested?
- surgically treated periprosthetic femur fracture
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Jul 2019
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with surgically treated periprosthetic femur fracture after hip arthroplasty
Who may be able to join
- patients with periprosthetic femur fracture after hip arthroplasty
Who cannot join
- Severe complications after surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center Study on Investigating the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty
To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip Arthroplasty
Read the detailed description
In the study，155 patients from multiple center with periprosthetic femur fracture after hip arthroplasty are planned to be recruited. All the patients are treated surgically according to Vancouver classification，and their fracture union，pain in fracture site and lower extremity length are evaluated at 6 months and 1 year postoperatively．Also Harris scores are used to assess hip function at the 2 time points.
- Conditions
- Periprosthetic Fractures
- Being tested
- surgically treated periprosthetic femur fracture
- Keywords
- Periprosthetic Fractures, Arthroplasty, Surgical procedures
- Medical subject headings
- Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgically treated periprosthetic femur fractureProcedure or surgery
patients with surgically treated periprosthetic femur fracture
| Study group | Role | What they receive |
|---|---|---|
| revision of periprosthetic fracture | patients with surgically treated periprosthetic femur fracture Receives: Procedure: surgically treated periprosthetic femur fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture union
fracture union from X-ray
Measured: 1 year after surgery
Secondary outcomes (3)
hip function
Harris Hip Score
Measured: 1 year after surgery
pain in fracture site
VAS score
Measured: 1 year after surgery
lower extremity length
The lengths of injured lower extremity
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic FracturesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pengzhang, Peking University People's Hospital
- Investigators
- Peng Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358186
- Sponsor's protocol ID
- csg-pffh
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- 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 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Investigating the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03358186
- Acronym / sponsor ID
- csg-pffh
- Conditions
- Periprosthetic Fractures
- Keywords
- Periprosthetic Fractures, Arthroplasty, Surgical procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 30 Nov 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.
To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip Arthroplasty
Detailed description
In the study，155 patients from multiple center with periprosthetic femur fracture after hip arthroplasty are planned to be recruited. All the patients are treated surgically according to Vancouver classification，and their fracture union，pain in fracture site and lower extremity length are evaluated at 6 months and 1 year postoperatively．Also Harris scores are used to assess hip function at the 2 time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| revision of periprosthetic fracture | – | Procedure: surgically treated periprosthetic femur fracturepatients with surgically treated periprosthetic femur fracture |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with surgically treated periprosthetic femur fracture after hip arthroplasty
Key inclusion criteria (1 listed)
- patients with periprosthetic femur fracture after hip arthroplasty
Key exclusion criteria (1 listed)
- Severe complications after surgery
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 |
|---|---|---|
| surgically treated periprosthetic femur fracturepatients with surgically treated periprosthetic femur fracture | Procedure or surgery | revision of periprosthetic fracture |
Primary outcome
fracture union
Time frame: 1 year after surgery
fracture union from X-ray
3 secondary outcomes
hip function
Time frame: 1 year after surgery
pain in fracture site
Time frame: 1 year after surgery
lower extremity length
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- 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.
Peng Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Fractures, run by Peking University People's Hospital.
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: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Yichong Zhang (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fracture union (time frame: 1 year after surgery). 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 30 Nov 2017.