Total Hip ArthroplastyNCT04987437
Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
An observational study of Total Hip Arthroplasty, run by Limacorporate S.p.a at 1 site in Italy.
Trial summary
Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem. 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?
- Friendly short stem
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2011to 6 Nov 2018
- Phase
- Observational
- 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
Study population: Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures
Who may be able to join
- Patients of both genders;
- Patients of all ages, but > 18 years old;
- Patients with primary and secondary coxarthrosis;
- Patients with rheumatoid arthritis;
- Patients with avascular necrosis;
- Patients with neck (not diaphyseal) fractures;
- Patients requiring a primary hip arthroplasty.
Who cannot join
- Patients requiring a revision of a previous stem;
- Patients with proven active or suspicious infections;
- Patients with known hypersensitivity to used materials;
- Patients with known active neoplastic or metastatic diseases;
- Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
- Patients with proven haemophilic disease;
Show all 9Show fewer
- Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
- Women with pregnancy or childbearing capacity or breast-feeding;
- Subjects already enrolled in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.
Read the detailed description
The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.
This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.
It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.
Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.
The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.
The evaluation has an internal control because the assessment of post-treatment data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge).
- Conditions
- Total Hip Arthroplasty
- Being tested
- Friendly short stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friendly short stemDevice
Total Hip Arthroplasty with Friendly Short stem
What is being measured
The primary outcome is the main question the study is designed to answer.
change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
Measured: up to 5 years FU
Change in percentage of the results of the Oxford Hip Score baseline to 1 year
Measured: up to 5 years FU
Change in Range Of Motion from baseline to 1 year.
Measured: up to 5 years FU
Secondary outcomes (3)
Radiographic stability
rate of signs of subsidence > 2mm or tilting
Measured: up to 5 years FU
Rate of failure
rate or revisions, loosening, failure of cement-stem interface, cement cracks, any definite change in the position of components
Measured: up to 5 years FU
Any possible adverse event or complication
Measured: up to 5 years FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start2 May 2011
- Primary completion6 Dec 2013
- Study completion6 Nov 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 Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Limacorporate S.p.aThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987437
- Sponsor's protocol ID
- H-02
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marega L, Gnagni P, Marega C, Marega F. Mid-term outcomes after primary total hip arthroplasty with a cemented short stem in an elderly patient cohort. Arch Orthop Trauma Surg. 2024 Dec 27;145(1):96. doi: 10.1007/s00402-024-05734-3.
PubMed 39729135
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
- ClinicalTrials.gov ID
- NCT04987437
- Acronym / sponsor ID
- H-02
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 2 May 2011 (actual)
- Primary completion
- 6 Dec 2013 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 3 Aug 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.
Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.
Detailed description
The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.
This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.
It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.
Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.
The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.
The evaluation has an internal control because the assessment of post-treatment data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures
Key inclusion criteria (7 listed)
- Patients of both genders;
- Patients of all ages, but > 18 years old;
- Patients with primary and secondary coxarthrosis;
- Patients with rheumatoid arthritis;
- Patients with avascular necrosis;
Key exclusion criteria (9 listed)
- Patients requiring a revision of a previous stem;
- Patients with proven active or suspicious infections;
- Patients with known hypersensitivity to used materials;
- Patients with known active neoplastic or metastatic diseases;
- Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
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 |
|---|---|---|
| Friendly short stemTotal Hip Arthroplasty with Friendly Short stem | Device | – |
Primary outcome
change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
Time frame: up to 5 years FU
Change in percentage of the results of the Oxford Hip Score baseline to 1 year
Time frame: up to 5 years FU
Change in Range Of Motion from baseline to 1 year.
Time frame: up to 5 years FU
3 secondary outcomes
Radiographic stability
Time frame: up to 5 years FU
Rate of failure
Time frame: up to 5 years FU
Any possible adverse event or complication
Time frame: up to 5 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 3 Aug 2021.
- Derived from this study: PubMed 39729135Marega L, Gnagni P, Marega C, Marega F. Mid-term outcomes after primary total hip arthroplasty with a cemented short stem in an elderly patient cohort. Arch Orthop Trauma Surg. 2024 Dec 27;145(1):96. doi: 10.1007/s00402-024-05734-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 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 Aug 2021. 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?
change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year (time frame: up to 5 years FU). 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 NCT04987437, 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 Aug 2021.