ArthroplastyNCT05606120
H-35 CL TRAUMA Cemented Femoral Stem
An observational study of Arthroplasty and Replacement, run by Limacorporate S.p.a at 1 site in Italy.
Trial summary
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- CL TRAUMA femoral stem
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 17 Sep 2025
- 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: The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023.
Who may be able to join
- Male or female;
- Age > 18 years old;
- All patients must give written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC);
- Adult patients in whom a decision has already been made to perform a partial or total hip arthroplasty with CL TRAUMA femoral stem as per indication for use. The decision to implant CL TRAUMA must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accordance with routine clinical practice at the study site concerned;
- Patients suffering from: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; or suffering from rheumatoid arthritis; or patients requiring treatment of femoral head and neck fractures;
- Patients able to comply with the protocol.
Who cannot join
- Adult patients with any CL TRAUMA femoral stem contraindication for use as reported in the current local Instruction for use;
- Patients with active or any suspected infection (on the affected hip or systemic);
- Patients suffering from acute or chronic osteomyelitis;
- Patients with confirmed nerve or muscle lesion compromising hip joint function;
- Patients with vascular or nerve diseases affecting the concerned limb;
- Patients with poor bone stock (such as osteoporosis or extended previous revision surgery) compromising the stability of the implant;
Show all 11Show fewer
- Patients with metabolic disorders which may impair fixation and stability of the implant;
- Any concomitant disease and dependence that might affect the implanted prosthesis;
- Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials;
- Patients currently participating in any other surgical intervention studies or pain management studies;
- 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 Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With CL TRAUMA Cemented Femoral Stem
Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- CL TRAUMA femoral stem
- Keywords
- Hip replacement, Cemented stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL TRAUMA femoral stemDevice
Hip arthroplasty according to the instruction for use.
| Study group | Role | What they receive |
|---|---|---|
| CL TRAUMA implanted patients | Patients who underwent hip arthroplasty with CL TRAUMA cemented femoral stem from 2017 to 2023. Receives: Device: CL TRAUMA femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is based upon Harris Hip score evaluation.
The primary endpoint is based upon patients' clinical recovery at the Survival Follow-up visit measured as Harris Hip Score greater than 80.
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and it is intended to evaluate various hip disabilities and methods of treatment in an adult population. It is a clinical outcome measurement administered by a qualified health care professional, such as a physician or a physical therapist. There are ten items covering four domains. The domains are: pain, function, absence of deformity, and range of motion.
The maximum score is 100 points. Results can be interpreted with the following:
- < 60 = failed result;
- 60-69 = poor result;
- 70-79 = fair;
- 80-90 = good
- 90-100 = excellent.
Measured: Performed only at survival follow-up (up to 7 years).
Secondary outcomes (3)
Radiographic implant evaluation and stability assessment at different routinely post-operative timepoints.
Imaging will be collected to evaluate the radiographic performance of the device, which will contribute to the overall efficacy evaluation of the CL TRAUMA femoral stem.
All X-rays performed during the clinical study fall within standard clinical practice.
Radiological assessment was carried out postoperatively at discharge, at 1 month and 24 months after the surgery. It included standard views, such as antero-posterior (AP) of the pelvis and lateral (LAT) of the affected hip.
Measured: Performed at discharge, 1 month follow-up, 2 years follow-up and at survival follow-up (up to 7 years).
Survivorship of the implant (Kaplan-Meier estimate) after surgery at survival follow-up.
The Kaplan-Meier estimate for implant revision will be calculated and shown graphically. The time from the initial operation to the revision date will be described in person-years, and the Poisson incidence rate and associated 95% CI (confidence interval) will be provided.
Measured: Performed only at survival follow-up (up to 7 years).
Safety assessment
Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.
Measured: From surgery to survival follow-up (up to 7 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Dec 2022
- Primary completion23 Jan 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 54 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
- NCT05606120
- Sponsor's protocol ID
- H-35
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2022
- Last updated
- 15 Jan 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With CL TRAUMA Cemented Femoral Stem
- ClinicalTrials.gov ID
- NCT05606120
- Acronym / sponsor ID
- H-35
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Hip replacement, Cemented stem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 4 Nov 2022 (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 CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL TRAUMA implanted patients | – | Device: CL TRAUMA femoral stemPatients who underwent hip arthroplasty with CL TRAUMA cemented femoral stem from 2017 to 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023.
Key inclusion criteria (6 listed)
- Male or female;
- Age > 18 years old;
- All patients must give written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC);
- Adult patients in whom a decision has already been made to perform a partial or total hip arthroplasty with CL TRAUMA femoral stem as per indication for use. The decision to implant CL TRAUMA must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accordance with routine clinical practice at the study site concerned;
- Patients suffering from: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; or suffering from rheumatoid arthritis; or patients requiring treatment of femoral head and neck fractures;
Key exclusion criteria (11 listed)
- Adult patients with any CL TRAUMA femoral stem contraindication for use as reported in the current local Instruction for use;
- Patients with active or any suspected infection (on the affected hip or systemic);
- Patients suffering from acute or chronic osteomyelitis;
- Patients with confirmed nerve or muscle lesion compromising hip joint function;
- Patients with vascular or nerve diseases affecting the concerned limb;
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 |
|---|---|---|
| CL TRAUMA femoral stemHip arthroplasty according to the instruction for use. | Device | CL TRAUMA implanted patients |
Primary outcome
The primary endpoint is based upon Harris Hip score evaluation.
Time frame: Performed only at survival follow-up (up to 7 years).
The primary endpoint is based upon patients' clinical recovery at the Survival Follow-up visit measured as Harris Hip Score greater than 80. The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and it is intended to evaluate various hip disabilities and methods of treatment in an adult population. It is a clinical outcome measurement administered by a qualified health care professional, such as a physician or a physical therapist. There are ten items covering four domains. The domains are: pain, function, absence of deformity, and range of motion. The maximum score is 100 points. Results can be interpreted with the following: * < 60 = failed result; * 60-69 = poor result; * 70-79 = fair; * 80-90 = good * 90-100 = excellent.
3 secondary outcomes
Radiographic implant evaluation and stability assessment at different routinely post-operative timepoints.
Time frame: Performed at discharge, 1 month follow-up, 2 years follow-up and at survival follow-up (up to 7 years).
Survivorship of the implant (Kaplan-Meier estimate) after surgery at survival follow-up.
Time frame: Performed only at survival follow-up (up to 7 years).
Safety assessment
Time frame: From surgery to survival follow-up (up to 7 years).
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 15 Jan 2026.
Related trials for Arthroplasty
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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 Arthroplasty and Replacement, 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 6 inclusion and 11 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 15 Jan 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 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?
The primary endpoint is based upon Harris Hip score evaluation. (time frame: Performed only at survival follow-up (up to 7 years).). 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 15 Jan 2026.