Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position

November 6, 2024 updated by: Tony Maher, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • both sexes
  • 18 years or older
  • acetabular defect paprosky 2b or 3a segemntal defect reconstructed with trabecualr metal augment in the flying buttress position.

Exclusion Criteria:

  • patients presented with active infection
  • pathological defects
  • pelvic discontinuity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult patients with acetabular defects requiring reconstruction
The acetabular defect was reconstructed by tarbecular metal augments in the flying buttress position
Procedure: Reconstruction of acetabular defect by trabecular metal augment
The augments were used in the flying buttress position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 years
Survivorship of the construct
Time Frame: 8years
The rate of construct survivorship using the kaplan meier survival analysis
8years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

September 6, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trabecular metal augments

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe