Intertrochanteric FracturesNCT03407131
Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients
A study testing Joint replacement surgery and Intramedullary nail fixation in people with Intertrochanteric Fractures, run by Peking University People's Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Intertrochanteric Fractures
- What is being tested?
- Joint replacement surgery and Intramedullary nail fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Mar 2019
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Intertrochanteric fractures of the femur need surgery
- Male and female, age more than 75 years old
- Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders
- The patient is still able to tolerate surgery through the anaesthesia and related department assessment
- Signed written informed consent
Who cannot join
- No complications associated with internal medicine
- Mild fracture displacement and conservative treatment required
- Multiple trauma involving more than one organ system
- Known to have progressive malignant neoplasms
- It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Fixation or Joint Replacement Therapy for Hip Fracture Patients Over 75 Years Old Combined With Multiple Internal Medicine Complications: a Prospective, Multicenter, Randomized Controlled Trial
To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.
Read the detailed description
Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.
- Conditions
- Intertrochanteric Fractures
- Being tested
- Joint replacement surgery, Intramedullary nail fixation
- Keywords
- Intertrochanteric fracture, Medical complications
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint replacement surgeryProcedure or surgery
Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
Intramedullary nail fixationProcedure or surgery
Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.
| Study group | Role | What they receive |
|---|---|---|
| Joint replacement | Experimental | Intertrochanteric fracture patients were treated with joint replacement surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. Receives: Procedure: Joint replacement surgery |
| Intramedullary nail fixation | Active comparator | Intertrochanteric fracture patients were treated with intramedullary nail fixation surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. Receives: Procedure: Intramedullary nail fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding related index
Postoperative drainage volume and bleeding volume during operation（Unit: ml）
Measured: Three days after the operation
Secondary outcomes (4)
Joint rehabilitation index
Early loading time
Measured: Three months after the operation
Complication rate
The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality
Measured: Three monthes after the operation
Functional rehabilitation index
Harris Scores of the two groups
Measured: Three months after the operation
Surgical related index
operation time of the two groups（Unit: minutes）
Measured: Three days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric FracturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, baoguojiang, Peking University People's Hospital
- Investigators
- Baoguo Jiang, Doctor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407131
- Sponsor's protocol ID
- PUPH20171228
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- 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 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Fixation or Joint Replacement Therapy for Hip Fracture Patients Over 75 Years Old Combined With Multiple Internal Medicine Complications: a Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03407131
- Acronym / sponsor ID
- PUPH20171228
- Conditions
- Intertrochanteric Fractures
- Keywords
- Intertrochanteric fracture, Medical complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 23 Jan 2018 (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 evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.
Detailed description
Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint replacement | Experimental | Procedure: Joint replacement surgeryIntertrochanteric fracture patients were treated with joint replacement surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. |
| Intramedullary nail fixation | Active comparator | Procedure: Intramedullary nail fixationIntertrochanteric fracture patients were treated with intramedullary nail fixation surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Intertrochanteric fractures of the femur need surgery
- Male and female, age more than 75 years old
- Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders
- The patient is still able to tolerate surgery through the anaesthesia and related department assessment
- Signed written informed consent
Key exclusion criteria (5 listed)
- No complications associated with internal medicine
- Mild fracture displacement and conservative treatment required
- Multiple trauma involving more than one organ system
- Known to have progressive malignant neoplasms
- It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study
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 |
|---|---|---|
| Joint replacement surgeryJoint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible. | Procedure or surgery | Joint replacement |
| Intramedullary nail fixationInternal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function. | Procedure or surgery | Intramedullary nail fixation |
Primary outcome
Bleeding related index
Time frame: Three days after the operation
Postoperative drainage volume and bleeding volume during operation（Unit: ml）
4 secondary outcomes
Joint rehabilitation index
Time frame: Three months after the operation
Complication rate
Time frame: Three monthes after the operation
Functional rehabilitation index
Time frame: Three months after the operation
Surgical related index
Time frame: Three days after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- 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.
Baoguo Jiang, Doctor study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint replacement surgery and Intramedullary nail fixation in people with Intertrochanteric Fractures, run by Peking University People's 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 5 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 23 Jan 2018. 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. 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?
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?
Bleeding related index (time frame: Three days after the operation). 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 23 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.