Acetabular AbnormalityNCT06678958
Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position
A study testing Reconstruction of acetabular defect by trabecular metal augment in people with Acetabular Abnormality, run by Ain Shams University.
Trial summary
This study hypothesize that trabecular metal augments used in the flying buttress position is a valid option with good results in the management of uncontained acetabular defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Abnormality
- What is being tested?
- Reconstruction of acetabular defect by trabecular metal augment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 6 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes
- 18 years or older
- acetabular defect paprosky 2b or 3a segemntal defect reconstructed with trabecualr metal augment in the flying buttress position.
Who cannot join
- patients presented with active infection
- pathological defects
- pelvic discontinuity
About this study
Official title: Intermediate Term Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position in the Management of Acetabular Defects
This study hypothesize that trabecular metal augments used in the flying buttress position is a valid option with good results in the management of uncontained acetabular defects.
- Conditions
- Acetabular Abnormality
- Being tested
- Reconstruction of acetabular defect by trabecular metal augment
- Keywords
- Acetabular augments, Flying buttress, Revision total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction of acetabular defect by trabecular metal augmentProcedure or surgery
The augments were used in the flying buttress position
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with acetabular defects requiring reconstruction | Experimental | The acetabular defect was reconstructed by tarbecular metal augments in the flying buttress position Receives: Procedure: Reconstruction of acetabular defect by trabecular metal augment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionl hip status
Functional outcome was assessed by oxford hip score the worst score is 12 and the best score is 60
Measured: 8 years
Survivorship of the construct
The rate of construct survivorship using the kaplan meier survival analysis
Measured: 8years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2022
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular AbnormalityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Maher, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678958
- Sponsor's protocol ID
- Trabecular metal augments
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Term Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position in the Management of Acetabular Defects
- ClinicalTrials.gov ID
- NCT06678958
- Acronym / sponsor ID
- Trabecular metal augments
- Conditions
- Acetabular Abnormality
- Keywords
- Acetabular augments, Flying buttress, Revision total hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 7 Nov 2024 (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.
This study hypothesize that trabecular metal augments used in the flying buttress position is a valid option with good results in the management of uncontained acetabular defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with acetabular defects requiring reconstruction | Experimental | Procedure: Reconstruction of acetabular defect by trabecular metal augmentThe acetabular defect was reconstructed by tarbecular metal augments in the flying buttress position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both sexes
- 18 years or older
- acetabular defect paprosky 2b or 3a segemntal defect reconstructed with trabecualr metal augment in the flying buttress position.
Key exclusion criteria (3 listed)
- patients presented with active infection
- pathological defects
- pelvic discontinuity
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 |
|---|---|---|
| Reconstruction of acetabular defect by trabecular metal augmentThe augments were used in the flying buttress position | Procedure or surgery | Adult patients with acetabular defects requiring reconstruction |
Primary outcome
Functionl hip status
Time frame: 8 years
Functional outcome was assessed by oxford hip score the worst score is 12 and the best score is 60
Survivorship of the construct
Time frame: 8years
The rate of construct survivorship using the kaplan meier survival analysis
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 7 Nov 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction of acetabular defect by trabecular metal augment in people with Acetabular Abnormality, run by Ain Shams University.
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 3 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: finished, as of the sponsor's last update on 7 Nov 2024. 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?
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?
Functionl hip status (time frame: 8 years). The study lists 2 primary outcomes in all. 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 7 Nov 2024.