Cup Position in THA With Standard Instruments



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:21 - Any
Updated:2/2/2019
Start Date:September 7, 2017
End Date:December 31, 2020
Contact:David Fawley, MS, MA
Email:dfawley1@its.jnj.com
Phone:574-371-4748

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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, 12 and 52 weeks postoperatively.

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:

1. Inclination success (as defined for the primary endpoint)

2. Version success (as defined for the primary endpoint)

3. 90-day complication rates

4. Change from preoperative baseline for the Harris Hip Score

5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)

6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index
value, if applicable)

7. Change from 6 week baseline for the Forgotten Joint Score

Inclusion Criteria:

1. All devices are to be used according to the approved indications

2. The patient is undergoing a standard of care hip replacement with the Pinnacle cup and
a Corail or Summit stem via the posterolateral, anterolateral, or direct lateral
approach with the patient in the lateral decubitus position.

3. 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.

4. Individuals who are willing and able to complete follow-up as specified by the study
protocol.

5. 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.

6. Individuals who are not bedridden.

7. Individuals who are a minimum age of 21 years at the time of consent.

Exclusion Criteria:

1. Active local or systemic infection.

2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected
limb rendering the procedure unjustified.

3. 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).

4. Charcot's or Paget's disease.

5. The Subject is a woman who is pregnant or lactating.

6. Subject had a contralateral amputation.

7. Previous partial hip replacement in affected hip.

8. Subject has participated in a clinical investigation with an investigational product
(drug or device) in the last three months.

9. Contralateral hip was replaced less than 6 months prior to surgery date

10. Subject is currently involved in any personal injury litigation, medical-legal or
worker's compensation claims.

11. 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.

12. Subject has a medical condition with less than 2 years of life expectancy.

13. 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.
We found this trial at
6
sites
2345 Court Drive
Gastonia, North Carolina 28054
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Gastonia, NC
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Charleston, South Carolina 29406
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Charleston, SC
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Grand Rapids, Michigan 49525
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Grand Rapids, MI
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Milan,
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New York, New York 10029
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New York, NY
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1980 Tamarack Road
Newark, Ohio 43055
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Newark, OH
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