New hip stem put to the test in 95 patients
NCT ID NCT07616895
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test a new cementless hip stem (Mfinity collared stem) in 95 adults needing total hip replacement due to osteoarthritis. The main goal is to see how many implants survive without needing revision after one year, with a follow-up at two years. Researchers will track any revisions, deaths, or dropouts to estimate the implant's performance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mfinity collared femoral stem (a cementless hip implant device)
- What this could lead to
- If successful, this could provide a safe and effective new option for hip replacement surgery.
- What could go wrong
- This is a small, early-stage study with no control group, so results may not apply to all patients. The implant could fail or require revision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 95 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use * Skeletally mature adult aged 18 years and older at the time of enrollment. * Ability to give informed consent. * Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period. Exclusion Criteria: * Not meeting the inclusion criteria. * Active infection within the affected hip joint. * Previous total hip replacement or hip fusion of the affected hip joint. * Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device. * Bone condition that may compromise the stability of the implant * Known allergy or hypersensitivity to the implant material * Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. * For women of childbearing potential\*: a positive pregnancy test * Patients with severe osteoarthritis in the contralateral hip or other joints that may interfere with the assessment of study outcomes. * Patients who have previously participated in this clinical trial. * a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women using one of the following birth control methods are not considered of childbearing potential: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable),intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
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