Patient SatisfactionNCT04333316
Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
A study testing large head and dual mobility cup in people with Patient Satisfaction and Hip Osteoarthritis, run by Tanta University.
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. Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Hip Osteoarthritis
- What is being tested?
- large head and dual mobility cup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Unilateral hip arthritis
- Age up to 65 years
- Body mass index (BMI) up to 35
- Modified Charnley comorbidity classification equal to A
Who cannot join
- 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
About this study
Official title: Principal Investigator
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.
Read the 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.
- Conditions
- Patient Satisfaction, Hip Osteoarthritis
- Being tested
- large head, dual mobility cup
- Keywords
- hip arthroplasty, satisfaction, dual mobility cup
- Medical subject headings
- Patient Satisfaction, Osteoarthritis, Hip, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large headProcedure or surgery
implantation of large head total hip
dual mobility cupProcedure or surgery
implantation of dual mobility total hip
| Study group | Role | What they receive |
|---|---|---|
| large head group | Other | study the postoperative patient's satisfaction Receives: Procedure: large head; Procedure: dual mobility cup |
| dual mobility group | Other | study the postoperative patient's satisfaction Receives: Procedure: large head; Procedure: dual mobility cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's satisfaction
measurement by patient's reported outcomes measures
Measured: about 5 years
clinical evaluation
WOMAC score
Measured: about 5 years
pain assessment
VAS score
Measured: about 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study startJan 2011
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed m. samy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333316
- Sponsor's protocol ID
- 42687
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 33252552
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT04333316
- Acronym / sponsor ID
- 42687
- Conditions
- Patient Satisfaction, Hip Osteoarthritis
- Keywords
- hip arthroplasty, satisfaction, dual mobility cup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| large head group | Other | Procedure: large head, Procedure: dual mobility cupstudy the postoperative patient's satisfaction |
| dual mobility group | Other | Procedure: large head, Procedure: dual mobility cupstudy the postoperative patient's satisfaction |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral hip arthritis
- Age up to 65 years
- Body mass index (BMI) up to 35
- Modified Charnley comorbidity classification equal to A
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| large headimplantation of large head total hip | Procedure or surgery | dual mobility group, large head group |
| dual mobility cupimplantation of dual mobility total hip | Procedure or surgery | dual mobility group, large head group |
Primary outcome
patient's satisfaction
Time frame: about 5 years
measurement by patient's reported outcomes measures
clinical evaluation
Time frame: about 5 years
WOMAC score
pain assessment
Time frame: about 5 years
VAS score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 33252552Samy 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing large head and dual mobility cup in people with Patient Satisfaction and Hip Osteoarthritis, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient's satisfaction (time frame: about 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.