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TerminatedNCT04070989Updated Dec 19, 2025Results posted

Pinnacle RSA Study

An interventional study of THA in Osteoarthritis and Degenerative Arthritis, sponsored by DePuy Orthopaedics. Terminated at 3 sites in Canada. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor decision to terminate early. Decision was not based on safety or efficacy of the study product.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study 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. This will be summarized for each surgical approach separately, as well as combined.

02

Conditions studied

  • Osteoarthritis
  • Degenerative Arthritis

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03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

First submitted after DePuy Orthopaedics became part of Johnson & Johnson.

Browse DePuy Orthopaedics studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
  15. Individual has a >45 kg/m2.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Posterior Approach

    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach

    Device: THA

  • Experimental
    Lateral Approach

    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach

    Device: THA

  • Experimental
    Anterior Approach

    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

    Device: THA

Interventions

  • DeviceTHA

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At 6 week and 2 years

  2. 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).

    Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

  3. 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.

    Time frame: At 6 weeks, 3 months, 6 months, 1 year and 2 years

Secondary outcomes

  1. 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

  2. Other RSA Measurements (X-Translations)

    Other RSA measurements (X translations in mm) at all time points

    Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years

  3. Other RSA Measurements (Z-Translations)

    Other RSA measurements (Z translations in mm) at all time points

    Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years

  4. Other RSA Measurements (Rotations)

    X, Y, and Z rotations in degrees at all time points

    Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years

  5. Linear Head Penetration

    Linear head penetration at 1 year and 2 years for each surgical approach separately was reported.

    Time frame: At 1 year and 2 years

  6. 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.

    Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

07

Results

Posted Oct 21, 2025
Limitations and caveats
Early Termination of the study; study was not terminated due to saftey concerns with the product.

Participant flow

Participant flow — Overall Study
MilestonePosterior ApproachLateral ApproachAnterior Approach
Started402024
Completed29100
Not completed111024
Withdrew: Death100
Withdrew: Study terminated by sponsor7823
Withdrew: Withdrawal by subject010
Withdrew: Inclusion/exclusion criteria not met201
Withdrew: Other110

Outcome measures

PrimaryMean 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

Time frame:
At 6 week and 2 years
Reported as:
Mean · mm
Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
mmPosterior ApproachLateral ApproachAnterior ApproachOverall Population
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 2yrs0.06 ± 0.2920.045 ± 0.501—0.055 ± 0.362
SecondaryRSA 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
Reported as:
Mean · mm
RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year
mmPosterior ApproachLateral ApproachAnterior ApproachOverall Population
RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up0.044 ± 0.11-0.065 ± 0.103-0.062 ± 0.272-0.025 ± 0.187
RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up0.13 ± 0.3140.047 ± 0.320-0.011 ± 0.1920.07 ± 0.289
RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up0.065 ± 0.2320.05 ± 0.377-0.12 ± 0.2870.032 ± 0.286
SecondaryOther RSA Measurements (X-Translations)

Other RSA measurements (X translations in mm) at all time points

Time frame:
At 6 weeks, 3 months, 6 months, 1 year, 2 years
Reported as:
Mean · mm
Other RSA Measurements (X-Translations)
mmPosterior ApproachLateral ApproachAnterior ApproachOverall Population
X-axis translations (mm) at 6 weeks0.009 ± 0.082-0.016 ± 0.2140.049 ± 0.1190.017 ± 0.134
X-axis translations (mm) at 3 months-0.085 ± 0.229-0.042 ± 0.2770.028 ± 0.321-0.033 ± 0.276
X-axis translations (mm) at 6 months-0.001 ± 0.271-0.02 ± 0.30.113 ± 0.4020.025 ± 0.317
X-axis translations (mm) at 1 year-0.029 ± 0.2840.06 ± 0.2830.146 ± 0.2610.022 ± 0.282
X-axis translations (mm) at 2 years-0.057 ± 0.372-0.026 ± 0.361—-0.047 ± 0.363
SecondaryOther RSA Measurements (Z-Translations)

Other RSA measurements (Z translations in mm) at all time points

Time frame:
At 6 weeks, 3 months, 6 months, 1 year, 2 years
Reported as:
Mean · mm
Other RSA Measurements (Z-Translations)
mmPosterior ApproachLateral ApproachAnterior ApproachOverall Population (Per Protocol Analysis)
Z-axis translations (mm) at 6 weeks-0.033 ± 0.134-0.06 ± 0.15-0.033 ± 0.227-0.039 ± 0.172
Z-axis translations (mm) at 3 months-0.087 ± 0.317-0.095 ± 0.3790.127 ± 0.409-0.013 ± 0.376
Z-axis translations (mm) at 6 months-0.023 ± 0.303-0.199 ± 0.341-0.004 ± 0.759-0.063 ± 0.476
Z-axis translations (mm) at 1 year-0.112 ± 0.2340.014 ± 0.41-0.095 ± 0.462-0.076 ± 0.325
Z-axis translations (mm) at 2 years-0.207 ± 0.344-0.061 ± 0.466—-0.161 ± 0.385
SecondaryOther RSA Measurements (Rotations)

X, Y, and Z rotations in degrees at all time points

Time frame:
At 6 weeks, 3 months, 6 months, 1 year, 2 years
Reported as:
Mean · Degrees
Other RSA Measurements (Rotations)
DegreesPosterior ApproachLateral ApproachAnterior ApproachOverall Per Protocol Analysis Set
X-axis Rotation at 6 Weeks0.023 ± 0.368-0.175 ± 0.6120.059 ± 0.55-0.009 ± 0.495
Y-axis Rotation at 6 weeks0.035 ± 0.4720.357 ± 0.588-0.033 ± 0.3720.085 ± 0.487
Z-axis Rotation at 6 weeks0.045 ± 0.350.135 ± 0.3840.026 ± 0.3770.059 ± 0.364
X-axis Rotation at 3 months-0.368 ± 1.046-0.021 ± 1.311-0.201 ± 0.528-0.209 ± 0.974
Y-axis Rotation at 3 months0.027 ± 0.9660.053 ± 1.7150.054 ± 0.560.044 ± 1.102
Z-axis Rotation at 3 months-0.196 ± 0.475-0.231 ± 0.710.343 ± 1.113-0.013 ± 0.841
X-axis Rotation at 6 months-0.241 ± 0.81-0.34 ± 0.8110.481 ± 3.181-0.069 ± 1.789
Y-axis Rotation at 6 months0.137 ± 0.9670.585 ± 1.043-0.254 ± 1.6930.145 ± 1.238
Z-axis Rotation at 6 months0.062 ± 0.5910.069 ± 0.5750.549 ± 1.680.196 ± 1.01
X-axis Rotation at 1 year-0.024 ± 0.5750.343 ± 1.467-0.943 ± 0.773-0.069 ± 0.988
Y-axis Rotation at 1 year0.043 ± 0.494-0.272 ± 1.7740.73 ± 0.7380.066 ± 1.049
Z-axis Rotation at 1 year0.067 ± 0.523-0.033 ± 0.636-0.306 ± 0.774-0.018 ± 0.596
X-axis Rotation at 2 years-0.223 ± 0.7030.26 ± 1.392—-0.072 ± 0.974
Y-axis Rotation at 2 years0.216 ± 0.801-0.156 ± 1.406—0.1 ± 1.019
Z-axis Rotation at 2 years0.284 ± 0.714-0.001 ± 0.793—0.195 ± 0.739
SecondaryLinear Head Penetration

Linear head penetration at 1 year and 2 years for each surgical approach separately was reported.

Time frame:
At 1 year and 2 years
Reported as:
Mean · mm
Linear Head Penetration
mmPosterior ApproachLateral ApproachAnterior Approach
Linear Head Penetration at 1 year f/up0.182 ± 0.1070.211 ± 0.090.286 ± 0.086
Linear Head Penetration at 2 years f/up0.228 ± 0.1010.321 ± 0.192—
SecondaryPatient 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.

Time frame:
Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Reported as:
Mean · Units on a scale
Patient Reported Outcome Measures (PROMs)- Harris Hip Score
Units on a scalePosterior ApproachLateral ApproachAnterior Approach
HHS at Pre-op57.6 ± 15.1449.47 ± 20.1661.23 ± 12.61
HHS at 6 weeks follow-up82.14 ± 11.5276.67 ± 15.9186.00 ± 14.07
HHS at 3 months follow-up90.08 ± 10.5189.00 ± 15.5893.18 ± 6.11
HHS at 6 months follow-up91.09 ± 11.2293.89 ± 9.5196.71 ± 5.50
HHS at 1 year follow-up94.93 ± 7.9596.27 ± 6.48100 ± 0
HHS at 2 years follow-up93.27 ± 12.5595.44 ± 7.99—
PrimaryPatient 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).

Time frame:
Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Reported as:
Mean · Units on a scale
Patient Reported Outcome Measures (PROMs)- HOOS Jr.
Units on a scalePosterior ApproachLateral ApproachAnterior Approach
HOOS Jr. at Pre-op52.61 ± 11.9254.47 ± 13.9952.88 ± 16.63
HOOS Jr. at 6 weeks follow-up78.99 ± 11.6880.22 ± 14.9675.78 ± 12.22
HOOS Jr. at 3 months follow-up83.17 ± 14.0288.37 ± 13.9189.07 ± 12.62
HOOS Jr. at 6 months follow-up85.7 ± 14.9890.64 ± 14.1989.89 ± 12.00
HOOS Jr. at 1 year follow-up92.71 ± 11.2291.7 ± 15.2797.54 ± 6.02
HOOS Jr. at 2 years follow-up89.76 ± 15.9894.5 ± 7.42—
PrimaryPatient 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.

Time frame:
At 6 weeks, 3 months, 6 months, 1 year and 2 years
Reported as:
Mean · Units on a scale
Patient Reported Outcome Measures (PROMs)- FJS-12
Units on a scalePosterior ApproachLateral ApproachAnterior Approach
FJS-12 Score at 6 weeks follow-up54.74 ± 26.1448.14 ± 29.755.88 ± 28.93
FJS-12 Score at 3 months follow-up63.35 ± 26.570.27 ± 31.7169.26 ± 29.48
FJS-12 Score at 6 months follow-up67.33 ± 29.7881.88 ± 18.9482.64 ± 20.06
FJS-12 Score at 1 year follow-up82.06 ± 22.5875.87 ± 27.9191.95 ± 10.79
FJS-12 Score at 2 years follow-up82.67 ± 23.7284.72 ± 11.02—

Adverse events

Collected over Day 0 up to 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Posterior Approach1/40 (2.5%)8/40 (20%)9/40 (22.5%)
Lateral Approach0/20 (0%)2/20 (10%)4/20 (20%)
Anterior Approach0/24 (0%)5/24 (20.8%)7/24 (29.2%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventPosterior ApproachLateral ApproachAnterior Approach
OsteoarthritisMusculoskeletal and connective tissue disorders5/402/201/24
TendonitisMusculoskeletal and connective tissue disorders0/400/201/24
CataractEye disorders0/400/201/24
Type 2 diabetes mellitusMetabolism and nutrition disorders0/400/201/24
Adrenocortical carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/400/201/24
Duodenal ulcerGastrointestinal disorders1/400/200/24
Gastrointestinal haemorrhageGastrointestinal disorders1/400/200/24
Gastrointestinal ulcerGastrointestinal disorders1/400/200/24
Corona virus infectionInfections and infestations1/400/200/24
InfluenzaInfections and infestations1/400/200/24
Most frequent other events
Showing 10 of 21
Most frequent other events
EventPosterior ApproachLateral ApproachAnterior Approach
Stitch abscessInfections and infestations0/402/200/24
Iliotibial band syndromeInjury, poisoning and procedural complications2/400/200/24
Incision site dischargeInjury, poisoning and procedural complications2/400/200/24
Incision site erythemaInjury, poisoning and procedural complications0/401/200/24
ArthralgiaMusculoskeletal and connective tissue disorders2/400/201/24
BursitisMusculoskeletal and connective tissue disorders0/401/201/24
Limb discomfortMusculoskeletal and connective tissue disorders0/401/200/24
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders0/401/200/24
Pain in extremityMusculoskeletal and connective tissue disorders0/401/200/24
CellulitisInfections and infestations0/401/200/24

Baseline characteristics

Safety analysis set included all enrolled participants who received total hip arthroplasty (THA) surgery. Participants were analyzed according to the surgical approach applied during the study.

Age, Continuous
Age, Continuous(years)Posterior ApproachLateral ApproachAnterior ApproachTotal
Mean69.53 ± 8.8565.0 ± 9.3960.5 ± 12.7265.87 ± 10.81
Sex: Female, Male
Sex: Female, Male(Participants)Posterior ApproachLateral ApproachAnterior ApproachTotal
Female2011940
Male2091544
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Posterior ApproachLateral ApproachAnterior ApproachTotal
Count of participants———0
Primary Diagnosis
Primary Diagnosis(Participants)Posterior ApproachLateral ApproachAnterior ApproachTotal
Osteoarthritis562334
Avascular necrosis1012
Degenerative Joint Disease3414048
BMI
BMI(kg/m2)Posterior ApproachLateral ApproachAnterior ApproachTotal
Mean31.19 ± 6.7330.36 ± 6.7530.32 ± 5.4330.74 ± 6.33
08

Study locations

3 sites
  • Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
    Winnipeg, Manitoba, Canada
  • QEII Health Sciences Centre & Dalhousie University
    Halifax, Nova Scotia, Canada
  • London Health Sciences Centre
    London, Ontario, Canada
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04070989
Lead sponsor
DePuy Orthopaedics
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
Dec 3, 2019
Primary completion
Jun 12, 2023
Completion
Jun 16, 2023
Results posted
Oct 21, 2025
Last update
Dec 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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