Femoral FracturesNCT06885359
CoCrMo LOCK Bipolar Femoral Heads FU
An observational study of Femoral Fractures and Hip Arthropathy, run by Limacorporate S.p.a at 1 site in Slovenia.
Trial summary
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar femoral heads… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fractures, Hip Arthropathy
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 28 Jan 2026to Dec 2028
- 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 CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards
Who may be able to join
- Displaced intracapsular hip fracture (Garden III-IV).
- Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar 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 CoCrMo LOCK Bipolar 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.
Slovenia1 site, 1 recruiting
- Recruiting
Splošna bolnišnica Celje
Celje, 3000
Dario Kalacun, +386 70 34 34 36, Dario.kalacun@sb-celje.si
About this study
Official title: A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar 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 CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar 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 LOCK Bipolar 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
- Femoral Fractures, Hip Arthropathy
- 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 |
|---|---|---|
| CoCrMo LOCK bipolar femoral head implanted patient | Patients who underwent hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1at January 2023 onwards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.
Measured: At 24 months after intraoperative visit
Secondary outcomes (8)
Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty
Measured: At 24 months after intraoperative visit
Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.
Measured: At 24 months after intraoperative visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty.
Measured: At 12 months after intraoperative visit
Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.
The Harris Hip Score goes from 0 to 100, which is the best result.
Measured: At 24 months after intraoperative visit
Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome
Measured: At 24 months after intraoperative visit
Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar 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: At 24 months after intraoperative visit
Comparison between pre-operative and 4-month walking ability.
Functional evaluation
At the pre-operative time-point, the ability to walk is categorized in:
- "able to walk without aids",
- "able to walk using one walking aid",
- "able to walk using two walking aids",
- "able to walk using the walking frame"
- "unable to walk" (wheelchair or bed-ridden subjects)
At the 4-month post-operative time-point, the ability to walk is investigated is categorized in:
- "maintained" (if the subject is able to walk independently as before, with aids if necessary)
- "not maintained" (if the subject needs support from another person or uses a wheelchair or is bed-ridden)
Measured: Performed at preoperative visit and 4months follow up visit
Comparison between pre-operative and 4-month residential status.
Daily habit
At pre-operative timepoint, subjects are categorized as subjects that before the fracture were used to live:
- at their own home (alone or with assistance),
- in a sheltered home for independent people,
- in a nursing home for people who need assistance with personal care.
At 4-month post-operative timepoint, the residential status is categorised in:
- maintained (if the subject is living in the same dwelling as before fracture),
- not maintained (if the subject moved to a sheltered accommodation or a nursing home)
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 posted20 Mar 2025
- Study start28 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies 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
- 60 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
- NCT06885359
- Sponsor's protocol ID
- H-46
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2025
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. 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 Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects With Hip Fracture
- ClinicalTrials.gov ID
- NCT06885359
- Acronym / sponsor ID
- H-46
- Conditions
- Femoral Fractures, Hip Arthropathy
- Keywords
- Femoral head, Partial Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 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 CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar 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 LOCK Bipolar 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 |
|---|---|---|
| CoCrMo LOCK bipolar femoral head implanted patient | – | –Patients who underwent hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1at January 2023 onwards. |
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 CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards
Key inclusion criteria (6 listed)
- Displaced intracapsular hip fracture (Garden III-IV).
- Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar 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 CoCrMo LOCK Bipolar 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 CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.
Time frame: At 24 months after intraoperative visit
8 secondary outcomes
Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty
Time frame: At 24 months after intraoperative visit
Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.
Time frame: At 24 months after intraoperative visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty.
Time frame: At 12 months after intraoperative visit
Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.
Time frame: At 24 months after intraoperative visit
Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
Time frame: At 24 months after intraoperative visit
Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
Time frame: At 24 months after intraoperative visit
Comparison between pre-operative and 4-month walking ability.
Time frame: Performed at preoperative visit and 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 7 Jul 2026.
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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 Femoral Fractures and Hip Arthropathy, run by Limacorporate S.p.a at 1 site in Slovenia.
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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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 Slovenia. 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 (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 CoCrMo LOCK Bipolar femoral heads at 24 months after surgery. (time frame: At 24 months after intraoperative 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 7 Jul 2026.