New hip implant put to the test: will it stay put?
NCT ID NCT04070989
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at a specific hip implant shell (the Pinnacle Acetabular Shell) used in total hip replacement. Researchers wanted to see how much the implant moved (migrated) over two years using a special X-ray technique called RSA. They also tracked how patients felt and functioned after surgery. The study included 100 people with severe hip arthritis or other hip problems needing a replacement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pinnacle Acetabular Shell (hip implant device)
- What this could lead to
- If successful, this could help surgeons choose the best surgical approach for hip replacement to reduce implant loosening.
- What could go wrong
- This was a small, early study that was terminated, so results may be limited. It only measured implant movement, not long-term outcomes.
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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100 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Jun 2023
- 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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21 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: 1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck 2. Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes 3. Individuals who are willing and able to return for follow-up as specified by the study protocol 4. Individuals who are a minimum age of 21 years at the time of consent 5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol Exclusion Criteria: 1. Individuals have active local or systemic infection 2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery 3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s) 4. Individuals with Charcot's or Paget's disease 5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA 6. Women that are pregnant or lactating 7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months at the time of consent into this study 8. Individuals that have amputations in either leg that would impact rehabilitation following surgery 9. Individuals who are bedridden. 10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months 11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims 12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements 13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia 14. Subject has a medical condition with less than 2 years life expectancy 15. Individual has a BMI \>45 kg/m2.
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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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Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
Winnipeg, Manitoba, Canada
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London Health Sciences Centre
London, Ontario, Canada
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QEII Health Sciences Centre & Dalhousie University
Halifax, Nova Scotia, Canada
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