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Cup Position in THA With Standard Instruments

Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Completed
CT.gov ID
NCT03189303
Collaborator
(none)
183
Enrollment
11
Locations
51.2
Actual Duration (Months)
16.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
183 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
Actual Study Start Date :
Sep 7, 2017
Actual Primary Completion Date :
May 19, 2021
Actual Study Completion Date :
Dec 14, 2021

Outcome Measures

Primary Outcome Measures

  1. 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: Inclination Success: within 10 degrees of the planned inclination Version Success: within 10 degrees of the planned version

Secondary Outcome Measures

  1. Inclination success [6 weeks]

    Inclination Success: within 10 degrees of the planned inclination

  2. Version success [6 weeks]

    Version success: within 10 degrees of the planned version

  3. 90 day postoperative complication rates [90 days postoperative]

    The number of subjects and the percentage of subjects with complications at 90 days post-operatively

  4. Harris Hip Score [Baseline and 6 and 12 weeks postoperative]

    Change from preoperative baseline for the Harris Hip Score

  5. Forgotten Joint Score [6 and 12 weeks postoperative]

    Change from 6 week baseline for the Forgotten Joint Score

  6. EQ-5D-5L dimension score [Baseline and 6 and 12 weeks postoperative]

    Mean change from baseline for the specified time points

  7. EQ-VAS score (subscore of EQ-5D-5L) [Baseline and 6 and 12 weeks postoperative]

    Mean change from baseline for the specified time points

  8. EQ-5D-5L index value (if applicable) [Baseline and 6 and 12 weeks postoperative]

    Mean change from baseline for the specified time points

  9. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orthopaedic Associates of Michigan Grand Rapids Michigan United States 49503
2 Mount Sinai Hospital New York New York United States 10029
3 Carolina Orthopaedic and Sports Medicine Center Gastonia North Carolina United States 28054
4 Orthopedic Specialists and Sports Medicine Newark Ohio United States 43055
5 Lowcountry Orthopaedics & Sports Medicine Charleston South Carolina United States 29406
6 Istituto Orthopedico Galeazzi IRCCS Milan Italy
7 Bravis Hospital Bergen op Zoom Netherlands
8 Maastricht University Medical Center Maastricht Netherlands
9 Canisius Wilhelmina Hospital Nijmegen Netherlands
10 Woodend Hospital Aberdeen Scotland United Kingdom
11 Glan Clwyd Hospital Rhyl Wales United Kingdom

Sponsors and Collaborators

  • DePuy Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT03189303
Other Study ID Numbers:
  • DSJ_15010
First Posted:
Jun 16, 2017
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Arthritis

Study Results

No Results Posted as of Feb 15, 2022