NCT04333316

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

7.6 years

First QC Date

March 30, 2020

Last Update Submit

April 1, 2020

Conditions

Patient SatisfactionHip Osteoarthritis

Keywords

hip arthroplastysatisfactiondual mobility cup

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

large head group

OTHER

study the postoperative patient's satisfaction

Procedure: large headProcedure: dual mobility cup

dual mobility group

OTHER

study the postoperative patient's satisfaction

Procedure: large headProcedure: dual mobility cup

Interventions

large headPROCEDURE

implantation of large head total hip

dual mobility grouplarge head group
dual mobility cupPROCEDURE

implantation of dual mobility total hip

dual mobility grouplarge head group

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33252552DERIVED

MeSH Terms

Conditions

Patient SatisfactionOsteoarthritis, HipPersonal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 3, 2020

Study Start

January 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

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