Surgical Procedure, UnspecifiedosteotomyNCT03193840
Posterior Wall Osteotomy for Old Acetabular Fracture
A study testing posterior wall osteotomy in people with Surgical Procedure, Unspecified, run by Hebei Medical University Third Hospital at 2 sites in China.
Trial summary
Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- posterior wall osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2017to 1 Apr 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acetabular fracture
- no surgical procedure has been obtained over 3 weeks
- deformed healing
- receive posterior wall osteotomy
- completed more than one year follow-up
Who cannot join
- accompanied with other fracture
- pathological fracture
- reject the posterior wall osteotomy
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Zhiyong Hou, M.D, +8618533112800, houzhiyong1234@126.com
Ruipeng Zhang, M.D
- Recruiting
Zhiyong Hou
Shijiazhuang, Hebei, 050051
Zhiyong Hou, M.D, +8618533112800, houzhiyong1234@126.com
Ruipeng Zhang, M.D
About this study
Official title: Surgical Treatment of Old Acetabular Fracture With Posterior Wall Osteotomy
Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.
Read the detailed description
More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied.
Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- posterior wall osteotomy
- Keywords
- old acetabular fracture; posterior wall osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior wall osteotomyProcedure or surgery
posterior wall osteotomy is conducted through Kocher-Langenbeck approach.
| Study group | Role | What they receive |
|---|---|---|
| old acetabular fracture | Experimental | posterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks. Receives: Procedure: posterior wall osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
frecture union time
the fracture line in the radiography
Measured: 4 months
Secondary outcomes (1)
complication
iatrogenic neurovascular injury
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start12 Jun 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyong Hou, Study chair, Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193840
- Sponsor's protocol ID
- ZRP1
- Acronym
- osteotomy
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 23 Jun 2017
- 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 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Old Acetabular Fracture With Posterior Wall Osteotomy
- ClinicalTrials.gov ID
- NCT03193840
- Acronym / sponsor ID
- osteotomy / ZRP1
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- old acetabular fracture; posterior wall osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 21 Jun 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.
Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.
Detailed description
More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied.
Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| old acetabular fracture | Experimental | Procedure: posterior wall osteotomyposterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- acetabular fracture
- no surgical procedure has been obtained over 3 weeks
- deformed healing
- receive posterior wall osteotomy
- completed more than one year follow-up
Key exclusion criteria (3 listed)
- accompanied with other fracture
- pathological fracture
- reject the posterior wall osteotomy
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 |
|---|---|---|
| posterior wall osteotomyposterior wall osteotomy is conducted through Kocher-Langenbeck approach. | Procedure or surgery | old acetabular fracture |
Primary outcome
frecture union time
Time frame: 4 months
the fracture line in the radiography
1 secondary outcome
complication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Zhiyong Hou study chair
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior wall osteotomy in people with Surgical Procedure, Unspecified, run by Hebei Medical University Third Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Hou (+8618533112800, houzhiyong1234@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frecture union time (time frame: 4 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 23 Jun 2017.