Hip Arthroplasty ReplacementNCT06873568
Cephalic Femoral Heads Follow Up
An observational study of Hip Arthroplasty Replacement and Femoral Fractures, run by Limacorporate S.p.a at 1 site in Slovakia.
Trial summary
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty Replacement, Femoral Fractures
- How many people
- 47 participants
- Where
- 1 siteSlovakia
- Study dates
- Oct 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards
Who may be able to join
- Displaced intracapsular hip fracture (Garden III-IV).
- Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.
- No concurrent joint disease at the time of the surgery.
- Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
- Ability to ambulate independently with or without walking aids before surgery.
- Subject willingness to participate.
Who cannot join
- Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
- Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.
- Pathological fracture secondary to malignant disease.
- Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
- Previous treatment to the same hip for a fracture at the time of the surgery.
- Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
- Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
- Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site
University Hospital J.A. Reimana
Prešov, 5898
Dominik Kobak, 051/701 1899, kobakd@fnsppresov.sk
About this study
Official title: A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture
Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.
Read the detailed description
The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).
- Conditions
- Hip Arthroplasty Replacement, Femoral Fractures
- Keywords
- femoral head, Partial hip arthroplasty
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards. | The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
Measured: From intraoperative to 24months follow up visit
Secondary outcomes (8)
Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Measured: From intraoperative to 24months follow up visit
Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Measured: From intraoperative to 24months follow up visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.
Baker classification is graded from 0 to 3, where 3 is the worst case. Grade 0: no erosion Grade 1: narrowing the arthicular cartilage, no erosion Grade 2: acetabular erosion and early migration Grade 3: protrusion acetabuli
Measured: 12 months follow up visit
Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.
The Harris Hip Score goes from 0 to 100, which is the best result.
Measured: 24 months follow up visit
Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome
Measured: 24 months follow up visit
Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
The pain Likert-scale is a 6-point scale:
- severe and spontaneous
- severe when walking
- tollerable
- occurs after activity
- light intermittent
- no pain
Measured: 24 months follow up visit
Comparison between pre-operative and 4-month walking ability.
Functional evaluation
Measured: Performed at preoperative visit to 4months follow up visit
Comparison between pre-operative and 4-month residential status.
Daily habit
Measured: Performed at preoperative visit and 4months follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthroplasty ReplacementStudies 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
- Retrospective
- Enrolment
- 47 participants (estimated)
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
- NCT06873568
- Sponsor's protocol ID
- H-45
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture
- ClinicalTrials.gov ID
- NCT06873568
- Acronym / sponsor ID
- H-45
- Conditions
- Hip Arthroplasty Replacement, Femoral Fractures
- Keywords
- femoral head, Partial hip arthroplasty
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Mar 2025 (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.
Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.
Detailed description
The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards. | – | –The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards
Key inclusion criteria (6 listed)
- Displaced intracapsular hip fracture (Garden III-IV).
- Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.
- No concurrent joint disease at the time of the surgery.
- Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
- Ability to ambulate independently with or without walking aids before surgery.
Key exclusion criteria (8 listed)
- Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
- Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.
- Pathological fracture secondary to malignant disease.
- Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
- Previous treatment to the same hip for a fracture at the time of the surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
Time frame: From intraoperative to 24months follow up visit
8 secondary outcomes
Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Time frame: From intraoperative to 24months follow up visit
Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Time frame: From intraoperative to 24months follow up visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.
Time frame: 12 months follow up visit
Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.
Time frame: 24 months follow up visit
Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
Time frame: 24 months follow up visit
Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
Time frame: 24 months follow up visit
Comparison between pre-operative and 4-month walking ability.
Time frame: Performed at preoperative visit to 4months follow up visit
Comparison between pre-operative and 4-month residential status.
Time frame: Performed at preoperative visit and 4months follow up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
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 Hip Arthroplasty Replacement and Femoral Fractures, run by Limacorporate S.p.a at 1 site in Slovakia.
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 6 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: opening soon, as of the sponsor's last update on 18 Mar 2025. 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 Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Novello (+39 3358162087, monica.novello@enovis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty. (time frame: From intraoperative to 24months follow up visit). 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 18 Mar 2025.