New hip implant tested for better Long-Term fit
NCT ID NCT03724058
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares a new hip implant cup (Trident II) to an older version to see if it stays just as stable in the bone after surgery. Researchers will track 87 patients aged 40-75 for up to 10 years using special X-rays to measure any implant movement. The goal is to ensure the new design provides reliable fixation and reduces the risk of loosening over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trident® II Clusterhole HA Acetabular Shell (hip implant device)
- What this could lead to
- If successful, this could confirm that the new implant is as stable as the current one, potentially offering a reliable option for hip replacement patients.
- What could go wrong
- This is a small, single-center study comparing two similar devices, so results may not apply to all patients or implants. The study only measures early stability, not long-term success.
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
-
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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87 people
The number who actually took part.
- Started
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Feb 2019
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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40 to 75 years
- 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: * Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form. * The subject is a male or non-pregnant female between 40 and 75 years of age. * Patients with a BMI \< 35. * Patients requiring uncemented primary THA, suitable for the use of the uncemented Trident® Hemi HA or Trident® II Clusterhole HA acetabular component in combination with any compatible Stryker femoral stem. * Patients with no clinical relevant disorders undergoing total hip arthroplasty. * Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA). * Patients who are physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule. Exclusion Criteria: * Patients who are unwilling to cooperate with the study protocol and follow-up schedule. * Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule. * Patients with rheumatoid arthritis hip as well as history of acetabular or femoral osteotomy. * Patients who had a THA on the contra-lateral side within last 6 months. * Patients who had or will need lower joint replacement for another joint within 6 month * Female patients that are pregnant or planning a pregnancy during the course of the study * Patients who require revision of a previously implanted THA. * Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2 \> 35) * Patients with active or suspected infection * Patients with active malignancy * Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. * Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which
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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
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Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
Hässleholm, 28138, Sweden
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