Hip OsteoarthritisNCT05930067
Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
A study testing Pinnacle Gription Acetabular Cup and Pinnacle Dual Mobility in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
Trial summary
The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Pinnacle Gription Acetabular Cup and Pinnacle Dual Mobility
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesCanada
- Study dates
- 2 May 2023to 30 May 2025
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
Who cannot join
- Individuals have active local or systemic infection.
- Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s).
- Individuals with Charcot's or Paget's disease.
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
- Women who are pregnant or lactating.
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- 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 6 months following the time of consent into this study. Individuals that have amputations in either leg that would impact rehabilitation following surgery.
- Individuals who are bedridden per the Investigators determination.
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a medical condition with less than 2 years life expectancy.
- Individual has a BMI >45 kg/m2.
- DSJ-2019-02 only: Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished neck
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Orthopaedic Innovation Centre
Winnipeg, Manitoba, R2K 2M9
About this study
The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
Read the detailed description
The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.
- Conditions
- Hip Osteoarthritis
- Being tested
- Pinnacle Gription Acetabular Cup, Pinnacle Dual Mobility
- Keywords
- Hip Replacement
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinnacle Gription Acetabular CupDevice
Pinnacle Gription cup with Corail/ACTIS stem
Pinnacle Dual MobilityDevice
Bi-Mentum AltrX liner
| Study group | Role | What they receive |
|---|---|---|
| Pinnacle Gription | Other | Pinnacle Gription Acetabular Cup Receives: Device: Pinnacle Gription Acetabular Cup |
| Pinnacle Dual Mobility | Other | Pinnacle Dual Mobility System Receives: Device: Pinnacle Dual Mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
Measured: Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year
Secondary outcomes (5)
Subsidence profiles
Comparing RSA exams at the specified time points to determine relative movement of the device
Measured: 6-months, 1-year, 2-year
Change of functional outcome over 2 year follow-up period (Harris Hip Score)
The Harris Hip Score (HHS) is a score used in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Pain and Function
The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Forgotten Joint Score (FJS)
The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Complications
Evaluate the type and frequency of the complications/adverse events.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start2 May 2023
- Primary completion12 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Concordia Joint Replacement Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930067
- Sponsor's protocol ID
- HS23122 - HS25079
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
- ClinicalTrials.gov ID
- NCT05930067
- Acronym / sponsor ID
- HS23122 - HS25079
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 2 May 2023 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 Jul 2023 (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.
The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
Detailed description
The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinnacle Gription | Other | Device: Pinnacle Gription Acetabular CupPinnacle Gription Acetabular Cup |
| Pinnacle Dual Mobility | Other | Device: Pinnacle Dual MobilityPinnacle Dual Mobility System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
Key exclusion criteria (15 listed)
- Individuals have active local or systemic infection.
- Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s).
- Individuals with Charcot's or Paget's disease.
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
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 |
|---|---|---|
| Pinnacle Gription Acetabular CupPinnacle Gription cup with Corail/ACTIS stem | Device | Pinnacle Gription |
| Pinnacle Dual MobilityBi-Mentum AltrX liner | Device | Pinnacle Dual Mobility |
Primary outcome
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
Time frame: Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
5 secondary outcomes
Subsidence profiles
Time frame: 6-months, 1-year, 2-year
Change of functional outcome over 2 year follow-up period (Harris Hip Score)
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Pain and Function
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Forgotten Joint Score (FJS)
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Complications
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
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 10 Dec 2025.
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
Thomas Turgeon, MD principal investigator
Concordia Joint Replacement Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pinnacle Gription Acetabular Cup and Pinnacle Dual Mobility in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
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 1 inclusion and 15 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year (time frame: Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year). 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 10 Dec 2025.