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

NCT ID: NCT04333316

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Satisfaction Hip Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is prospective study was carried out on 180 patients with a unilateral arthritic hip between January 2011 and August 2018. Patients were divided into two groups, each group included 90 patients. Group A included patients received total hip with a large head (32-36mm.) made of cobalt-chrome. The femoral component was a cementless porous coated stem. The cup was a cementless porous coated Trilogy cup and was inserted press fit with primary additional one to three screws. Group B included those received total hip with a dual mobility cup
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

large head group

study the postoperative patient's satisfaction

Group Type OTHER

large head

Intervention Type PROCEDURE

implantation of large head total hip

dual mobility cup

Intervention Type PROCEDURE

implantation of dual mobility total hip

dual mobility group

study the postoperative patient's satisfaction

Group Type OTHER

large head

Intervention Type PROCEDURE

implantation of large head total hip

dual mobility cup

Intervention Type PROCEDURE

implantation of dual mobility total hip

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

large head

implantation of large head total hip

Intervention Type PROCEDURE

dual mobility cup

implantation of dual mobility total hip

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ahmed m. samy

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Samy AM, Mahmoud AA, El-Tantawy A. Dual Mobility Cup: Does It Improve Patient's Satisfaction After Total Hip Arthroplasty? A Prospective Comparative Randomized Study. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1141-e1150. doi: 10.5435/JAAOS-D-20-00882.

Reference Type DERIVED
PMID: 33252552 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

42687

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.