Cup Position in THA With Standard Instruments

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis
• Intervention / Treatment: Device: Primary Uncemented Total Hip Arthroplasty

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:

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

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Istituto Orthopedico Galeazzi IRCCS
• Netherlands
  • Bergen op Zoom, Netherlands
    • Bravis hospital
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Nijmegen, Netherlands
    • Canisius Wilhelmina Hospital
• United Kingdom
  • Scotland
    • Aberdeen, Scotland, United Kingdom
      • Woodend Hospital
  • Wales
    • Rhyl, Wales, United Kingdom
      • Glan Clwyd Hospital
• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Orthopaedic Associates of Michigan
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • Carolina Orthopaedic and Sports Medicine Center
  • Ohio
    • Newark, Ohio, United States, 43055
      • Orthopedic Specialists and Sports Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Orthopaedics & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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, Summit, or Actis 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inclination success	Inclination Success: within 10 degrees of the planned inclination	6 weeks
Version success	Version success: within 10 degrees of the planned version	6 weeks
90 day postoperative complication rates	The number of subjects and the percentage of subjects with complications at 90 days post-operatively	90 days postoperative
Harris Hip Score	Change from preoperative baseline for the Harris Hip Score	Baseline and 6 and 12 weeks postoperative
Forgotten Joint Score	Change from 6 week baseline for the Forgotten Joint Score	6 and 12 weeks postoperative
EQ-5D-5L dimension score	Mean change from baseline for the specified time points	Baseline and 6 and 12 weeks postoperative
EQ-VAS score (subscore of EQ-5D-5L)	Mean change from baseline for the specified time points	Baseline and 6 and 12 weeks postoperative
EQ-5D-5L index value (if applicable)	Mean change from baseline for the specified time points	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.	Baseline and 6 and 12 weeks postoperative

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): May 19, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: DSJ_15010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes