Fracture of AcetabulumPhase 4NCT01437150
Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
A Phase 4 study testing Anatomical locking plate and The Reconstructive Plate in people with Fracture of Acetabulum, run by Peifu Tang at 1 site in China.
Trial summary
The purpose of this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Acetabulum
- What is being tested?
- Anatomical locking plate and The Reconstructive Plate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Feb 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the acetabular posterior wall fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operation.
- Provision of informed consent by patient or legal guardian.
- No other major trauma.
Who cannot join
- Refuse to participate.
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected acetabular.
- Infection around the acetabular (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
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- Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Trial locations and contacts
1 site in 1 country.
China1 site
Orthopedics department; The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
About this study
The purpose of this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture.
Read the detailed description
Acetabular fractures were very common in high-energy injury, because of the anatomic of acetabular was in deep location and the complex form cause the diagnosis and treatment was difficult. For most of displaced acetabular fractures, the preferred treatment is open reduction and internal fixation. The purpose of surgery is to restore acetabular integrity and stability, allow early exercise, decrease complication. Acetabular posterior wall fractures were the most common, the current clinical application fixation of acetabular fractures were common plate and reconstruction steel plate. But when the acetabular posterior wall was fracture, some patients were not satisfied after surgery. The reason is mainly because the reconstruction plate need remoulding in surgery, and it not only led to the extension of operation time, but also cause poor attach. Otherwise, the reconstruction plate need location the angle of screw in surgery. If the operator lack of experience will make into the harm surrounding vessels and nerves. Some research has achieved the improvement from the anatomy of acetabular fractures in the locking plate. But there is not any plate match with the anatomy of the acetabular posterior wall.
This anatomical bone plate was designed base on before plate and had patent protection which is used in clinical trial. It was a new type of internal fixation of acetabular posterior wall fracture, this plate improve the shortcomings of existing technology, provides a pre-formed anatomical fixation plate , the direction of the locking screw holes. This design provide a better attach of acetabular posterior wall, more safe use the screw, making more stable and reliable fixation. This fixation plate was not only suitable for an experienced doctor, but also suitable for a less experienced doctors in theory. They can quickly and accurately fixed in its correct position, thus this fixation plate have advantages of improve surgical success rates, shorter hospital stay, reduce disease painful and it can used in all adult patients.
- Conditions
- Fracture of Acetabulum
- Being tested
- Anatomical locking plate, The Reconstructive Plate
- Keywords
- surgery, fixation, bone plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical locking plateDevice
Also called WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7
This is a new fixation treat for acetabular posterior wall fracture.
The Reconstructive PlateProcedure or surgery
Also called The Reconstructive Plate System
Reconstructive plate was used very common in treatment of acetabular fracture.
| Study group | Role | What they receive |
|---|---|---|
| Simple posterior wall fracture | Experimental | Simple posterior wall fracture means the fracture was only occurred in the posterior wall of acetabular. Receives: Device: Anatomical locking plate; Procedure: The Reconstructive Plate |
| Complex posterior wall fracture | Experimental | Complex posterior wall fracture means the fracture was not only occurred in the posterior wall of acetabular, but also occurred in other part of acetabular. Receives: Device: Anatomical locking plate; Procedure: The Reconstructive Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing condition
Bone healing condition was checked by radiological examination.
Measured: six months
Secondary outcomes (3)
Rates of revision surgery
Measured: one year
Patient quality of life
SF-36, ADL, FIM
Measured: one year
Complications
mortality, nonunion, implant breakage/failure, infection, DVT
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of AcetabulumStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peifu Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peifu Tang, Chinese PLA General Hospital
- Investigators
- Tang Peifu, Dr., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437150
- Sponsor's protocol ID
- PLAGH OD 11
- Status last verified
- Feb 2015
- First submitted
- 1 Sep 2011
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
- ClinicalTrials.gov ID
- NCT01437150
- Acronym / sponsor ID
- PLAGH OD 11
- Conditions
- Fracture of Acetabulum
- Keywords
- surgery, fixation, bone plate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peifu TangUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Sep 2011 (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 this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture.
Detailed description
Acetabular fractures were very common in high-energy injury, because of the anatomic of acetabular was in deep location and the complex form cause the diagnosis and treatment was difficult. For most of displaced acetabular fractures, the preferred treatment is open reduction and internal fixation. The purpose of surgery is to restore acetabular integrity and stability, allow early exercise, decrease complication. Acetabular posterior wall fractures were the most common, the current clinical application fixation of acetabular fractures were common plate and reconstruction steel plate. But when the acetabular posterior wall was fracture, some patients were not satisfied after surgery. The reason is mainly because the reconstruction plate need remoulding in surgery, and it not only led to the extension of operation time, but also cause poor attach. Otherwise, the reconstruction plate need location the angle of screw in surgery. If the operator lack of experience will make into the harm surrounding vessels and nerves. Some research has achieved the improvement from the anatomy of acetabular fractures in the locking plate. But there is not any plate match with the anatomy of the acetabular posterior wall.
This anatomical bone plate was designed base on before plate and had patent protection which is used in clinical trial. It was a new type of internal fixation of acetabular posterior wall fracture, this plate improve the shortcomings of existing technology, provides a pre-formed anatomical fixation plate , the direction of the locking screw holes. This design provide a better attach of acetabular posterior wall, more safe use the screw, making more stable and reliable fixation. This fixation plate was not only suitable for an experienced doctor, but also suitable for a less experienced doctors in theory. They can quickly and accurately fixed in its correct position, thus this fixation plate have advantages of improve surgical success rates, shorter hospital stay, reduce disease painful and it can used in all adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple posterior wall fracture | Experimental | Device: Anatomical locking plate, Procedure: The Reconstructive PlateSimple posterior wall fracture means the fracture was only occurred in the posterior wall of acetabular. |
| Complex posterior wall fracture | Experimental | Device: Anatomical locking plate, Procedure: The Reconstructive PlateComplex posterior wall fracture means the fracture was not only occurred in the posterior wall of acetabular, but also occurred in other part of acetabular. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the acetabular posterior wall fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operation.
Key exclusion criteria (9 listed)
- Refuse to participate.
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected acetabular.
- Infection around the acetabular (i.e., soft tissue or bone).
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 |
|---|---|---|
| Anatomical locking plateAlso: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7This is a new fixation treat for acetabular posterior wall fracture. | Device | Complex posterior wall fracture, Simple posterior wall fracture |
| The Reconstructive PlateAlso: The Reconstructive Plate SystemReconstructive plate was used very common in treatment of acetabular fracture. | Procedure or surgery | Complex posterior wall fracture, Simple posterior wall fracture |
Primary outcome
Bone healing condition
Time frame: six months
Bone healing condition was checked by radiological examination.
3 secondary outcomes
Rates of revision surgery
Time frame: one year
Patient quality of life
Time frame: one year
Complications
Time frame: one year
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 6 Feb 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.
Tang Peifu, Dr. study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anatomical locking plate and The Reconstructive Plate in people with Fracture of Acetabulum, run by Peifu Tang 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 7 inclusion and 9 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 6 Feb 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone healing condition (time frame: six 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 6 Feb 2015.