Hip implant performance under review in completed study
NCT ID NCT05606120
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked back at 54 people who had a hip replacement with a specific part called the CL TRAUMA cemented stem. The goal was to see if the part was safe and worked well. Researchers measured how well patients could move and if they had pain using a standard hip score.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
54 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female; 2. Age \> 18 years old; 3. All patients must give written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC); 4. 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; 5. 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; 6. Patients able to comply with the protocol. Exclusion Criteria: 1. Adult patients with any CL TRAUMA femoral stem contraindication for use as reported in the current local Instruction for use; 2. Patients with active or any suspected infection (on the affected hip or systemic); 3. Patients suffering from acute or chronic osteomyelitis; 4. Patients with confirmed nerve or muscle lesion compromising hip joint function; 5. Patients with vascular or nerve diseases affecting the concerned limb; 6. Patients with poor bone stock (such as osteoporosis or extended previous revision surgery) compromising the stability of the implant; 7. Patients with metabolic disorders which may impair fixation and stability of the implant; 8. Any concomitant disease and dependence that might affect the implanted prosthesis; 9. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials; 10. Patients currently participating in any other surgical intervention studies or pain management studies; 11. Female patients who are pregnant, nursing or planning a pregnancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Azienda Ospedale Università di Padova
Padova, Padova, 35128, Italy
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