Cup Position in THA With Standard Instruments

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

• Registration Number: NCT03189303
• Lead Sponsor: DePuy Orthopaedics

Brief 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.

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 Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Study Start: 2017-09-07
• Primary Completion: 2021-05-19
• Study Completion: 2021-12-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite success of cup inclination and cup version.	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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

Orthopaedic Associates of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Carolina Orthopaedic and Sports Medicine Center; 🇺🇸 Gastonia, North Carolina, United States

Orthopedic Specialists and Sports Medicine; 🇺🇸 Newark, Ohio, United States

Glan Clwyd Hospital; 🇬🇧 Rhyl, Wales, United Kingdom

Bravis Hospital; 🇳🇱 Bergen op Zoom, Netherlands

Istituto Orthopedico Galeazzi IRCCS; 🇮🇹 Milan, Italy

Lowcountry Orthopaedics & Sports Medicine; 🇺🇸 Charleston, South Carolina, United States

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Woodend Hospital; 🇬🇧 Aberdeen, Scotland, United Kingdom

Mount Sinai Hospital; 🇺🇸 New York, New York, United States