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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04333316
Other study ID # 42687
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date August 2018

Study information

Verified date April 2020
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 65 Years
Eligibility 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 Design


Intervention

Procedure:
large head
implantation of large head total hip
dual mobility cup
implantation of dual mobility total hip

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Outcome

Type Measure Description Time frame Safety issue
Primary patient's satisfaction measurement by patient's reported outcomes measures about 5 years
Primary clinical evaluation WOMAC score about 5 years
Primary pain assessment VAS score about 5 years
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