Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
Primary Purpose
Patient Satisfaction, Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
large head
dual mobility cup
Sponsored by
About this trial
This is an interventional treatment trial for Patient Satisfaction focused on measuring hip arthroplasty, satisfaction, dual mobility cup
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
large head group
dual mobility group
Arm Description
study the postoperative patient's satisfaction
study the postoperative patient's satisfaction
Outcomes
Primary Outcome Measures
patient's satisfaction
measurement by patient's reported outcomes measures
clinical evaluation
WOMAC score
pain assessment
VAS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04333316
Brief Title
Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
Official Title
Principal Investigator
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction, Hip Osteoarthritis
Keywords
hip arthroplasty, satisfaction, dual mobility cup
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
large head group
Arm Type
Other
Arm Description
study the postoperative patient's satisfaction
Arm Title
dual mobility group
Arm Type
Other
Arm Description
study the postoperative patient's satisfaction
Intervention Type
Procedure
Intervention Name(s)
large head
Intervention Description
implantation of large head total hip
Intervention Type
Procedure
Intervention Name(s)
dual mobility cup
Intervention Description
implantation of dual mobility total hip
Primary Outcome Measure Information:
Title
patient's satisfaction
Description
measurement by patient's reported outcomes measures
Time Frame
about 5 years
Title
clinical evaluation
Description
WOMAC score
Time Frame
about 5 years
Title
pain assessment
Description
VAS score
Time Frame
about 5 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
33252552
Citation
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.
Results Reference
derived
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Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
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