OsteoarthritisNCT04070989

Pinnacle RSA Study

A study testing THA in people with Osteoarthritis and Degenerative Arthritis, run by DePuy Orthopaedics at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Osteoarthritis, Degenerative Arthritis
What is being tested?: THA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesCanada
Study dates: 3 Dec 2019to 16 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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
Individuals who are willing and able to return for follow-up as specified by the study protocol
Individuals who are a minimum age of 21 years at the time of consent
Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Who cannot join

Individuals have active local or systemic infection
Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery
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)
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 that are pregnant or lactating

Show all 15Show fewer

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
Individuals that have amputations in either leg that would impact rehabilitation following surgery
Individuals who are bedridden.
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 psychological disorders 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 severe 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

QEII Health Sciences Centre & Dalhousie University
Halifax, Nova Scotia
London Health Sciences Centre
London, Ontario
Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell

Conditions: Osteoarthritis, Degenerative Arthritis
Being tested: THA
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THADevice
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Study groups in NCT04070989
Study group	Role	What they receive
Posterior Approach	Experimental	Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach Receives: Device: THA
Lateral Approach	Experimental	Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach Receives: Device: THA
Anterior Approach	Experimental	Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach Receives: Device: THA

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined
Measured: At 6 week and 2 years
Patient Reported Outcome Measures (PROMs)- HOOS Jr.
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome).
Measured: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Patient Reported Outcome Measures (PROMs)- FJS-12
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness.
Measured: At 6 weeks, 3 months, 6 months, 1 year and 2 years

Secondary outcomes (6)

RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year
Measured: At 3 months, 6 months and 1 year
Other RSA Measurements (X-Translations)
Other RSA measurements (X translations in mm) at all time points
Measured: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Other RSA Measurements (Z-Translations)
Other RSA measurements (Z translations in mm) at all time points
Measured: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Other RSA Measurements (Rotations)
X, Y, and Z rotations in degrees at all time points
Measured: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Linear Head Penetration
Linear head penetration at 1 year and 2 years for each surgical approach separately was reported.
Measured: At 1 year and 2 years
Patient Reported Outcome Measures (PROMs)- Harris Hip Score
The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result.
Measured: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 201916 Jun 2023

First posted28 Aug 2019
Study start3 Dec 2019
Primary completion12 Jun 2023
Study completion16 Jun 2023

Why it stopped: Sponsor decision to terminate early. Decision was not based on safety or efficacy of the study product.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04070989
Sponsor's protocol ID: DSJ_2018_02
Status last verified: Dec 2025
First submitted: 24 Jul 2019
Last updated: 19 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at https://yoda.yale.edu

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
ClinicalTrials.gov ID: NCT04070989
Acronym / sponsor ID: DSJ_2018_02
Conditions: Osteoarthritis, Degenerative Arthritis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to terminate early. Decision was not based on safety or efficacy of the study product.
Enrolment: 100 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 3 Dec 2019 (actual)
Primary completion: 12 Jun 2023 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Posterior Approach	Experimental	Device: THAPinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach
Lateral Approach	Experimental	Device: THAPinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach
Anterior Approach	Experimental	Device: THAPinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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
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
Individuals who are willing and able to return for follow-up as specified by the study protocol
Individuals who are a minimum age of 21 years at the time of consent
Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Key exclusion criteria (15 listed)

Individuals have active local or systemic infection
Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery
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)
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
THAPinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem	Device	Anterior Approach, Lateral Approach, Posterior Approach

Primary outcome

Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
Time frame: At 6 week and 2 years
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined
Patient Reported Outcome Measures (PROMs)- HOOS Jr.
Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome).
Patient Reported Outcome Measures (PROMs)- FJS-12
Time frame: At 6 weeks, 3 months, 6 months, 1 year and 2 years
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness.

6 secondary outcomes

RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year
Time frame: At 3 months, 6 months and 1 year
Other RSA Measurements (X-Translations)
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Other RSA Measurements (Z-Translations)
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Other RSA Measurements (Rotations)
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Linear Head Penetration
Time frame: At 1 year and 2 years
Patient Reported Outcome Measures (PROMs)- Harris Hip Score
Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posterior Approach	40	29
Lateral Approach	20	10
Anterior Approach	24	0

Primary outcome: Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years

Time frame: At 6 week and 2 years. Mean (Standard Deviation). Unit: mm

Measure	Posterior Approach n = 27	Lateral Approach n = 15	Anterior Approach n = 22	Overall Population n = 64
RSA Measured Subsidence (Y-axis Translation) at 6 weeks	-0.001 (0.065)	-0.03 (0.094)	-0.036 (0.133)	-0.02 (0.099)
RSA Measured Subsidence (Y-axis Translation) at 2yrs	0.06 (0.292)	0.045 (0.501)	–	0.055 (0.362)

Population analysed: Per Protocol Analysis Set

Primary outcome: Patient Reported Outcome Measures (PROMs)- HOOS Jr.

Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years. Mean (Standard Deviation). Unit: Units on a scale

Measure	Posterior Approach n = 27	Lateral Approach n = 15	Anterior Approach n = 22
HOOS Jr. at Pre-op	52.61 (11.92)	54.47 (13.99)	52.88 (16.63)
HOOS Jr. at 6 weeks follow-up	78.99 (11.68)	80.22 (14.96)	75.78 (12.22)
HOOS Jr. at 3 months follow-up	83.17 (14.02)	88.37 (13.91)	89.07 (12.62)
HOOS Jr. at 6 months follow-up	85.7 (14.98)	90.64 (14.19)	89.89 (12.00)
HOOS Jr. at 1 year follow-up	92.71 (11.22)	91.7 (15.27)	97.54 (6.02)
HOOS Jr. at 2 years follow-up	89.76 (15.98)	94.5 (7.42)	–

Population analysed: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.

Primary outcome: Patient Reported Outcome Measures (PROMs)- FJS-12

Time frame: At 6 weeks, 3 months, 6 months, 1 year and 2 years. Mean (Standard Deviation). Unit: Units on a scale

Measure	Posterior Approach n = 27	Lateral Approach n = 13	Anterior Approach n = 22
FJS-12 Score at 6 weeks follow-up	54.74 (26.14)	48.14 (29.7)	55.88 (28.93)
FJS-12 Score at 3 months follow-up	63.35 (26.5)	70.27 (31.71)	69.26 (29.48)
FJS-12 Score at 6 months follow-up	67.33 (29.78)	81.88 (18.94)	82.64 (20.06)
FJS-12 Score at 1 year follow-up	82.06 (22.58)	75.87 (27.91)	91.95 (10.79)
FJS-12 Score at 2 years follow-up	82.67 (23.72)	84.72 (11.02)	–

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Posterior Approach	8 of 40 (20%)	9 of 40 (22.5%)	1 of 40
Lateral Approach	2 of 20 (10%)	4 of 20 (20%)	0 of 20
Anterior Approach	5 of 24 (20.8%)	7 of 24 (29.2%)	0 of 24

Limitations and caveats (from the sponsor): Early Termination of the study; study was not terminated due to saftey concerns with the product.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at https://yoda.yale.edu

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing THA in people with Osteoarthritis and Degenerative Arthritis, run by DePuy Orthopaedics at 3 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 5 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: stopped early, as of the sponsor's last update on 19 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 3 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?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years (time frame: At 6 week and 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070989.

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 19 Dec 2025.