Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?

April 1, 2020 updated by: ahmed m. samy, Tanta University

Principal Investigator

Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

Study Type

Interventional

Enrollment (Actual)

180

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

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral hip arthritis
  • Age up to 65 years
  • Body mass index (BMI) up to 35
  • Modified Charnley comorbidity classification equal to A

Exclusion Criteria:

  • Neurological deficit (e.g. Parkinsonism, stroke)
  • Bone type c not fit for cementless fixation
  • Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
  • Any patient with psychiatric disorders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: large head group
study the postoperative patient's satisfaction
Procedure: large head
implantation of large head total hip
Procedure: dual mobility cup
implantation of dual mobility total hip
Other: dual mobility group
study the postoperative patient's satisfaction
Procedure: large head
implantation of large head total hip
Procedure: dual mobility cup
implantation of dual mobility total hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's satisfaction
Time Frame: about 5 years
measurement by patient's reported outcomes measures
about 5 years
clinical evaluation
Time Frame: about 5 years
WOMAC score
about 5 years
pain assessment
Time Frame: about 5 years
VAS score
about 5 years

Collaborators and Investigators

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

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2011

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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