Dual Mobility Cup: Does it Improve Patient's Satisfaction... | NCT04333316

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

NCT04333316

Sponsor

Tanta University

Status

Completed

Last Update Posted

Apr 3, 2020Actual

Enrollment

180Actual

Phase

Not Applicable

Conditions

Patient Satisfaction
Hip Osteoarthritis

Interventions

large head
dual mobility cup

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Mar 30, 2020

First Submission Date that Met QC Criteria

Apr 1, 2020

First Posted Date

Apr 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
large head group	Other	study the postoperative patient's satisfaction	Procedure: large head Procedure: dual mobility cup
dual mobility group	Other	study the postoperative patient's satisfaction	Procedure: large head Procedure: dual mobility cup

Interventions

Name	Type	Description	Arm Group Labels	Other Names
large head	Procedure	implantation of large head total hip	dual mobility group large head group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33252552	Derived	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.

See Also Links

Not provided

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction
D015207	Osteoarthritis, Hip
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior
D010003	Osteoarthritis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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