Total Hip ArthroplastyNCT04831918
Cemented Acetabular Cups Clinical Study
A study testing Mueller cemented cups in people with Total Hip Arthroplasty, run by Limacorporate S.p.a at 1 site in Italy.
Trial summary
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Mueller cemented cups
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 31 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
- The patient diagnosis is one or more of the following:
- Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;
- Patient with avascular necrosis of the femoral head or fracture of the femoral neck;
- Patient with congenital or acquired deformity;
- Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.
- The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
Who cannot join
- The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:
- Acute or chronic infections, local or systemic infections;
- Serious muscular, neurological or vascular diseases affecting the concerned limb;
- Any concomitant disease and dependence that might affect the implanted prosthesis;
- Allergy to material;
- Metal-on-metal systems: patients with renal impairment.
- Patient's age<18
- Female patients who are pregnant, nursing, or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Mueller cemented cups
- Keywords
- Cemented acetabular cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mueller cemented cupsDevice
Patients undergo total hip arthroplasty with the implant of Mueller cemented cups
| Study group | Role | What they receive |
|---|---|---|
| Mueller cemented cups | Experimental | Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component. Receives: Device: Mueller cemented cups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80
Measured: 2 years Follow up
Secondary outcomes (6)
Radiographic evaluation and stability assessment of the implant up to 2 years FU
Radiographic stability, radiographically detectable complications
Measured: 6 weeks, 1 year and 2 years FU
Clinical progression of HOOS up to 2 years FU, compared to the baseline
Hip disability and osteoarthritis outcome score (HOOS) is a patient-reported outcome measurement, that ranges from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms
Measured: 6 weeks, 1 year and 2 years FU
Change in TUG from preoperative up to 2 years FU
Timed Up and Go
Measured: 6 weeks, 1 year and 2 years FU
Clinical progression of HHS up to 1 year FU, compared to the baseline
Harris Hip Score
Measured: 6 weeks, 1 year
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery
Measured: 2 years FU
Incidence of device-related AE/SAE up to 2 years of follow-up
Adverse events and device deficiencies
Measured: 6 weeks, 1 year and 2 years FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Marega, Principal investigator, Ospedale San Camillo di Trento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831918
- Sponsor's protocol ID
- H-31
- Status last verified
- Feb 2024
- First submitted
- 1 Apr 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups
- ClinicalTrials.gov ID
- NCT04831918
- Acronym / sponsor ID
- H-31
- Conditions
- Total Hip Arthroplasty
- Keywords
- Cemented acetabular cup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Apr 2021 (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.
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mueller cemented cups | Experimental | Device: Mueller cemented cupsPatients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
- The patient diagnosis is one or more of the following:
- The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
Key exclusion criteria (8 listed)
- The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:
- Acute or chronic infections, local or systemic infections;
- Serious muscular, neurological or vascular diseases affecting the concerned limb;
- Any concomitant disease and dependence that might affect the implanted prosthesis;
- Allergy to material;
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 |
|---|---|---|
| Mueller cemented cupsPatients undergo total hip arthroplasty with the implant of Mueller cemented cups | Device | Mueller cemented cups |
Primary outcome
Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
Time frame: 2 years Follow up
HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80
6 secondary outcomes
Radiographic evaluation and stability assessment of the implant up to 2 years FU
Time frame: 6 weeks, 1 year and 2 years FU
Clinical progression of HOOS up to 2 years FU, compared to the baseline
Time frame: 6 weeks, 1 year and 2 years FU
Change in TUG from preoperative up to 2 years FU
Time frame: 6 weeks, 1 year and 2 years FU
Clinical progression of HHS up to 1 year FU, compared to the baseline
Time frame: 6 weeks, 1 year
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery
Time frame: 2 years FU
Incidence of device-related AE/SAE up to 2 years of follow-up
Time frame: 6 weeks, 1 year and 2 years FU
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 4 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Luca Marega principal investigator
Ospedale San Camillo di Trento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mueller cemented cups in people with Total Hip Arthroplasty, run by Limacorporate S.p.a at 1 site in Italy.
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 7 inclusion and 8 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery (time frame: 2 years Follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2024.