Pinnacle RSA Study

Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04070989
Collaborator
(none)
90
3
3
61.1
30
0.5

Study Details

Study Description

Brief Summary

The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.

Condition or Disease Intervention/Treatment Phase
  • Device: THA
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
Actual Study Start Date :
Dec 3, 2019
Anticipated Primary Completion Date :
Jun 20, 2024
Anticipated Study Completion Date :
Jan 6, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Posterior Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach

Device: THA
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Experimental: Lateral Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach

Device: THA
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Experimental: Anterior Approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

Device: THA
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Outcome Measures

Primary Outcome Measures

  1. Mean superior cup migration (subsidence) at 2 years [2 years]

    RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years for each surgical approach separately, as well as combined

Secondary Outcome Measures

  1. RSA measured cup subsidence at 3 months [3 months]

    RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell

  2. X-axis translation of acetabular shell at 3 months [3 months]

    RSA measured X-axis translation of acetabular shell in mm

  3. Z-axis translation of acetabular shell at 3 months [3 months]

    RSA measured Z-axis translation of acetabular shell in mm

  4. X-axis rotation of the acetabular shell at 3 months [3 months]

    RSA measured X-axis rotation of the acetabular shell measured in degrees

  5. Y-axis rotation of the acetabular shell at 3 months [3 months]

    RSA measured Y-axis rotation of the acetabular shell measured in degrees

  6. Z-axis rotation of the acetabular shell at 3 months [3 months]

    RSA measured Z-axis rotation of the acetabular shell measured in degrees

  7. Maximal total point motion of the acetabular shell at 3 months [3 months]

    RSA measured maximal total point motion of the acetabular shell in mm

  8. Harris Hip Score at 3 months [3 months]

    Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.

  9. HOOS Jr. Score at 3 months [3 months]

    Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health.

  10. FJS-12 at 3 months [3 months]

    Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.

  11. RSA measured cup subsidence at 6 months [6 months]

    RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell

  12. X-axis translation of acetabular shell at 6 months [6 months]

    RSA measured X-axis translation of acetabular shell in mm

  13. Z-axis translation of acetabular shell at 6 months [6 months]

    RSA measured Z-axis translation of acetabular shell in mm

  14. X-axis rotation of the acetabular shell at 6 months [6 months]

    RSA measured X-axis rotation of the acetabular shell measured in degrees

  15. Y-axis rotation of the acetabular shell at 6 months [6 months]

    RSA measured Y-axis rotation of the acetabular shell measured in degrees

  16. Z-axis rotation of the acetabular shell at 6 months [6 months]

    RSA measured Z-axis rotation of the acetabular shell measured in degrees

  17. Maximal total point motion of the acetabular shell at 6 months [6 months]

    RSA measured maximal total point motion of the acetabular shell in mm

  18. Harris Hip Score at 6 months [6 months]

    Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.

  19. HOOS Jr. Score at 6 months [6 months]

    Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health.

  20. FJS-12 at 6 months [6 months]

    Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.

  21. RSA measured cup subsidence at 1 year [1 year]

    RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell

  22. X-axis translation of acetabular shell at 1 year [1 year]

    RSA measured X-axis translation of acetabular shell in mm

  23. Z-axis translation of acetabular shell at 1 year [1 year]

    RSA measured Z-axis translation of acetabular shell in mm

  24. X-axis rotation of the acetabular shell at 1 year [1 year]

    RSA measured X-axis rotation of the acetabular shell measured in degrees

  25. Y-axis rotation of the acetabular shell at 1 year [1 year]

    RSA measured Y-axis rotation of the acetabular shell measured in degrees

  26. Z-axis rotation of the acetabular shell at 1 year [1 year]

    RSA measured Z-axis rotation of the acetabular shell measured in degrees

  27. Maximal total point motion of the acetabular shell at 1 year [1 year]

    RSA measured maximal total point motion of the acetabular shell in mm

  28. Harris Hip Score at 1 year [1 year]

    Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.

  29. HOOS Jr. Score at 1 year [1 year]

    Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health.

  30. FJS-12 at 1 year [1 year]

    Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.

  31. X-axis translation of acetabular shell at 2 years [2 years]

    RSA measured X-axis translation of acetabular shell in mm

  32. Z-axis translation of acetabular shell at 2 years [2 years]

    RSA measured Z-axis translation of acetabular shell in mm

  33. X-axis rotation of the acetabular shell at 2 years [2 years]

    RSA measured X-axis rotation of the acetabular shell measured in degrees

  34. Y-axis rotation of the acetabular shell at 2 years [2 years]

    RSA measured Y-axis rotation of the acetabular shell measured in degrees

  35. Z-axis rotation of the acetabular shell at 2 years [2 years]

    RSA measured Z-axis rotation of the acetabular shell measured in degrees

  36. Maximal total point motion of the acetabular shell at 2 years [2 years]

    RSA measured maximal total point motion of the acetabular shell in mm

  37. Harris Hip Score at 2 years [2 years]

    Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.

  38. HOOS Jr. Score at 2 years [2 years]

    Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health.

  39. FJS-12 at 2 years [2 years]

    Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.

  40. Linear head penetration at 1 year [1 year]

    Amount of linear head penetration compared to baseline (6 weeks) measured in mm

  41. Linear head penetration at 2 years [2 years]

    Amount of linear head penetration compared to baseline (6 weeks) measured in mm

Other Outcome Measures

  1. Correlation of functional and health status outcomes vs. RSA [2 years]

    Analyses to examine the correlation of functional and health status outcomes vs. RSA observations may be explored

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck

  2. Individuals who are able to speak, read and comprehend the informed patient 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

  3. Individuals who are willing and able to return for follow-up as specified by the study protocol

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

  5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Exclusion Criteria:
  1. Individuals have active local or systemic infection

  2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery

  3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s)

  4. Individuals with Charcot's or Paget's disease

  5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA

  6. Women that are pregnant or lactating

  7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months at the time of consent into this study

  8. Individuals that have amputations in either leg that would impact rehabilitation following surgery

  9. Individuals who are bedridden.

  10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months

  11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims

  12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements

  13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia

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

  15. Individual has a BMI >45 kg/m2.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba Winnipeg Manitoba Canada
2 QEII Health Sciences Centre & Dalhousie University Halifax Nova Scotia Canada
3 London Health Sciences Centre London Ontario Canada

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:
NCT04070989
Other Study ID Numbers:
  • DSJ_2018_02
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022