Osteoarthritis; Rheumatoid Arthritis; Post Traumatic ArthritisNCT03189303
Cup Position in THA With Standard Instruments
An observational study of Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis, run by DePuy Orthopaedics at 11 sites in 4 countries.
Trial summary
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis
- What is being tested?
- Primary Uncemented Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 183 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 7 Sep 2017to 14 Dec 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who the investigator deems to be a candidate for a primary total hip arthroplasty (THA) using the study devices (Pinnacle cup with a Corail or Summit stem) in a primary uncemented THA.
Who may be able to join
- All devices are to be used according to the approved indications
- The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit, or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position.
- Individuals who are able to speak, read, and comprehend the Informed 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 complete follow-up as specified by the study protocol.
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
- Individuals who are not bedridden.
- Individuals who are a minimum age of 21 years at the time of consent.
Who cannot join
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- 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 fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
- Subject had a contralateral amputation.
Show all 13Show fewer
- Previous partial hip replacement in affected hip.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Contralateral hip was replaced less than 6 months prior to surgery date
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Subject was diagnosed and is 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 of life expectancy.
- Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
Lowcountry Orthopaedics & Sports Medicine
Charleston, South Carolina, 29406
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina, 28054
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503
Mount Sinai Hospital
New York, New York, 10029
Orthopedic Specialists and Sports Medicine
Newark, Ohio, 43055
Netherlands3 sites
Bravis Hospital
Bergen op Zoom
Maastricht University Medical Center
Maastricht
Canisius Wilhelmina Hospital
Nijmegen
United Kingdom2 sites
Woodend Hospital
Aberdeen, Scotland
Glan Clwyd Hospital
Rhyl, Wales
About this study
Official title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
Read the detailed description
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:
Primary endpoint:
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.
Secondary endpoints:
- Inclination success (as defined for the primary endpoint)
- Version success (as defined for the primary endpoint)
- 90-day complication rates
- Change from preoperative baseline for the Harris Hip Score
- Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)
- Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)
- Change from 6 week baseline for the Forgotten Joint Score
- Being tested
- Primary Uncemented Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Uncemented Total Hip ArthroplastyDevice
The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite success of cup inclination and cup version.
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks:
- Inclination Success: within 10 degrees of the planned inclination
- Version Success: within 10 degrees of the planned version
Measured: 6 weeks
Secondary outcomes (9)
Inclination success
Inclination Success: within 10 degrees of the planned inclination
Measured: 6 weeks
Version success
Version success: within 10 degrees of the planned version
Measured: 6 weeks
90 day postoperative complication rates
The number of subjects and the percentage of subjects with complications at 90 days post-operatively
Measured: 90 days postoperative
Harris Hip Score
Change from preoperative baseline for the Harris Hip Score
Measured: Baseline and 6 and 12 weeks postoperative
Forgotten Joint Score
Change from 6 week baseline for the Forgotten Joint Score
Measured: 6 and 12 weeks postoperative
EQ-5D-5L dimension score
Mean change from baseline for the specified time points
Measured: Baseline and 6 and 12 weeks postoperative
EQ-VAS score (subscore of EQ-5D-5L)
Mean change from baseline for the specified time points
Measured: Baseline and 6 and 12 weeks postoperative
EQ-5D-5L index value (if applicable)
Mean change from baseline for the specified time points
Measured: Baseline and 6 and 12 weeks postoperative
Radiographic Outcomes
Radiographs will be read by an independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be compared to radiographs taken at later time points (12 weeks). Parameters measured include subsidence, migration, inclination and version angles, osteolysis, and radiolucency.
Measured: Baseline and 6 and 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start7 Sep 2017
- Primary completion19 May 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis; Rheumatoid Arthritis; Post Traumatic ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189303
- Sponsor's protocol ID
- DSJ_15010
- Status last verified
- Feb 2022
- First submitted
- 14 Jun 2017
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Fawley D, Bernard T, Thomason HC 3rd, Zagra L, Ten Broeke RHM, Johnson K. Early functional recovery outcomes and return to work after primary total hip arthroplasty: a novel patient reported outcomes questionnaire. J Orthop Surg Res. 2024 Jul 26;19(1):434. doi: 10.1186/s13018-024-04937-z.
PubMed 39061099Meermans G, Fawley D, Zagra L, Ten Broeke RHM, Johnson K, Bernard T, Thomason HC 3rd. Accuracy of cup placement compared with preoperative surgeon targets in primary total hip arthroplasty using standard instrumentation and techniques: a global, multicenter study. J Orthop Traumatol. 2024 May 10;25(1):25. doi: 10.1186/s10195-024-00766-2.
PubMed 38727945
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
- ClinicalTrials.gov ID
- NCT03189303
- Acronym / sponsor ID
- DSJ_15010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 16 Jun 2017 (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.
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
Detailed description
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:
Primary endpoint:
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.
Secondary endpoints:
- Inclination success (as defined for the primary endpoint)
- Version success (as defined for the primary endpoint)
- 90-day complication rates
- Change from preoperative baseline for the Harris Hip Score
- Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)
- Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)
- Change from 6 week baseline for the Forgotten Joint Score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who the investigator deems to be a candidate for a primary total hip arthroplasty (THA) using the study devices (Pinnacle cup with a Corail or Summit stem) in a primary uncemented THA.
Key inclusion criteria (7 listed)
- All devices are to be used according to the approved indications
- The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit, or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position.
- Individuals who are able to speak, read, and comprehend the Informed 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 complete follow-up as specified by the study protocol.
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
Key exclusion criteria (13 listed)
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- 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 fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
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 |
|---|---|---|
| Primary Uncemented Total Hip ArthroplastyThe study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem | Device | – |
Primary outcome
Composite success of cup inclination and cup version.
Time frame: 6 weeks
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: 1. Inclination Success: within 10 degrees of the planned inclination 2. Version Success: within 10 degrees of the planned version
9 secondary outcomes
Inclination success
Time frame: 6 weeks
Version success
Time frame: 6 weeks
90 day postoperative complication rates
Time frame: 90 days postoperative
Harris Hip Score
Time frame: Baseline and 6 and 12 weeks postoperative
Forgotten Joint Score
Time frame: 6 and 12 weeks postoperative
EQ-5D-5L dimension score
Time frame: Baseline and 6 and 12 weeks postoperative
EQ-VAS score (subscore of EQ-5D-5L)
Time frame: Baseline and 6 and 12 weeks postoperative
EQ-5D-5L index value (if applicable)
Time frame: Baseline and 6 and 12 weeks postoperative
Radiographic Outcomes
Time frame: Baseline and 6 and 12 weeks postoperative
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 15 Feb 2022.
- Derived from this study: PubMed 39061099Fawley D, Bernard T, Thomason HC 3rd, Zagra L, Ten Broeke RHM, Johnson K. Early functional recovery outcomes and return to work after primary total hip arthroplasty: a novel patient reported outcomes questionnaire. J Orthop Surg Res. 2024 Jul 26;19(1):434. doi: 10.1186/s13018-024-04937-z.
- Derived from this study: PubMed 38727945Meermans G, Fawley D, Zagra L, Ten Broeke RHM, Johnson K, Bernard T, Thomason HC 3rd. Accuracy of cup placement compared with preoperative surgeon targets in primary total hip arthroplasty using standard instrumentation and techniques: a global, multicenter study. J Orthop Traumatol. 2024 May 10;25(1):25. doi: 10.1186/s10195-024-00766-2.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis, run by DePuy Orthopaedics at 11 sites in 4 countries.
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 7 inclusion and 13 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, United Kingdom, Italy. 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?
Composite success of cup inclination and cup version. (time frame: 6 weeks). 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 NCT03189303, which also lists 2 linked publications.
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 15 Feb 2022.