OsteoarthritisPIN DMNCT05357664

PINNACLE® DM RSA Study

A study testing Total Hip Arthroplasty and Revision Total Hip Arthroplasty 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

Search all trials

Trial summary

The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct 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, Revision Arthroplasty
What is being tested?: Total Hip Arthroplasty and Revision Total Hip Arthroplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 3 sitesCanada
Study dates: 6 Oct 2022to 9 Feb 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 (typically due to non-inflammatory degenerative joint disease).
failed previous hip surgery.
or dislocation risks.
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.

Show all 9Show fewer

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 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.

Show all 16Show 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 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.
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

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® Dual Mobility Construct

Conditions: Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
Being tested: Total Hip Arthroplasty, Revision Total Hip Arthroplasty
Medical subject headings: Osteoarthritis

What participants receive

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

Total Hip ArthroplastyDevice
Also called THA
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Revision Total Hip ArthroplastyDevice
Also called RTHA
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Study groups in NCT05357664
Study group	Role	What they receive
Total Hip Arthroplasty	Experimental	Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses Receives: Device: Total Hip Arthroplasty
Revision Total Hip Arthroplasty	Experimental	Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses Receives: Device: Revision Total Hip Arthroplasty

What is being measured

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

Superior Cup Migration
Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)
Measured: 2 years

Secondary outcomes (6)

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: 6 weeks post operative
HOOS Jr Score
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty
Measured: 6 weeks
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 and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome
Measured: 6 weeks
Linear Head Penetration
Femoral head penetration into the polyethylene liner component will be determined and measured radiographically
Measured: 6 weeks, 1 year, 2 years
RSA Measured Subsidence (Superior Cup Migration)
Superior migration of the acetabular cup will be measured using RSA
Measured: 3 months, 6 months and 1 year
Additional RSA Measurements
Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points
Measured: 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.

6 Oct 20229 Feb 2023

First posted3 May 2022
Study start6 Oct 2022
Primary completion20 Dec 2022
Study completion9 Feb 2023

Why it stopped: Business decision made not to fund study

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: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05357664
Sponsor's protocol ID: DSJ_2019_02
Acronym: PIN DM
Status last verified: Mar 2024
First submitted: 27 Apr 2022
Last updated: 18 Apr 2024
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?

See locations

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. 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® Dual Mobility Construct
ClinicalTrials.gov ID: NCT05357664
Acronym / sponsor ID: PIN DM / DSJ_2019_02
Conditions: Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision made not to fund study
Enrolment: 11 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 6 Oct 2022 (actual)
Primary completion: 20 Dec 2022 (actual)
Study completion: 9 Feb 2023 (actual)
First posted: 3 May 2022 (actual)
Results: Posted 18 Apr 2024

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: 2

Arm	Type	Receives
Total Hip Arthroplasty	Experimental	Device: Total Hip ArthroplastyPinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Revision Total Hip Arthroplasty	Experimental	Device: Revision Total Hip ArthroplastyPinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Who may qualify

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

Key inclusion criteria (9 listed)

Individuals requiring primary THA for:
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 (16 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
Total Hip ArthroplastyAlso: THAPinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses	Device	Total Hip Arthroplasty
Revision Total Hip ArthroplastyAlso: RTHAPinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses	Device	Revision Total Hip Arthroplasty

Primary outcome

Superior Cup Migration
Time frame: 2 years
Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)

6 secondary outcomes

Harris Hip Score
Time frame: 6 weeks post operative
HOOS Jr Score
Time frame: 6 weeks
FJS-12
Time frame: 6 weeks
Linear Head Penetration
Time frame: 6 weeks, 1 year, 2 years
RSA Measured Subsidence (Superior Cup Migration)
Time frame: 3 months, 6 months and 1 year
Additional RSA Measurements
Time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years

Results and safety

Results posted to the registry on 18 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PINNACLE Dual Mobility System	11	0

Primary outcome: Superior Cup Migration

Time frame: 2 years

Population analysed: Study subjects who reach two years follow-up will undergo radiostereometric analysis of the study hip to determine if the acetabular cup has migrated from its post-operative position. Please note: data is not reported because the study was terminated at 6 weeks, therefore 2-year radiostereometric analyses could not be performed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected up to the six-week time point. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PINNACLE Dual Mobility System	1 of 11 (9.1%)	2 of 11 (18.2%)	0 of 11

Limitations and caveats (from the sponsor): Study was terminated prior to subjects reaching three-month timepoint; therefore, only secondary endpoint data at six-weeks was collected. RSA evaluations are performed once all subjects have completed follow-up at a protocol prescribed timepoint. Since the study was terminated following the enrollment of eleven subjects, no RSA evaluations took place.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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

Related trials for Osteoarthritis

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

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, Concordia Hip and Knee Institute & University of Manitoba

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

Questions about this trial

What is this clinical trial studying?

A study testing Total Hip Arthroplasty and Revision Total Hip Arthroplasty 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 9 inclusion and 16 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 18 Apr 2024. 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 18 Apr 2024). 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?

Superior Cup Migration (time frame: 2 years). 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 NCT05357664.

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 18 Apr 2024.