Pinnacle RSA Study

Osteoarthritis Clinical Trial

Official title:

Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04070989
• Other study ID #: DSJ_2018_02
• Status: Terminated
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: June 16, 2023

Study information

• Verified date: July 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: June 16, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of functional and health status outcomes vs. RSA	Analyses to examine the correlation of functional and health status outcomes vs. RSA observations may be explored	2 years
Primary	Mean superior cup migration (subsidence) at 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	2 years
Secondary	RSA measured cup subsidence at 3 months	RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell	3 months
Secondary	X-axis translation of acetabular shell at 3 months	RSA measured X-axis translation of acetabular shell in mm	3 months
Secondary	Z-axis translation of acetabular shell at 3 months	RSA measured Z-axis translation of acetabular shell in mm	3 months
Secondary	X-axis rotation of the acetabular shell at 3 months	RSA measured X-axis rotation of the acetabular shell measured in degrees	3 months
Secondary	Y-axis rotation of the acetabular shell at 3 months	RSA measured Y-axis rotation of the acetabular shell measured in degrees	3 months
Secondary	Z-axis rotation of the acetabular shell at 3 months	RSA measured Z-axis rotation of the acetabular shell measured in degrees	3 months
Secondary	Maximal total point motion of the acetabular shell at 3 months	RSA measured maximal total point motion of the acetabular shell in mm	3 months
Secondary	Harris Hip Score at 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.	3 months
Secondary	HOOS Jr. Score at 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.	3 months
Secondary	FJS-12 at 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.	3 months
Secondary	RSA measured cup subsidence at 6 months	RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell	6 months
Secondary	X-axis translation of acetabular shell at 6 months	RSA measured X-axis translation of acetabular shell in mm	6 months
Secondary	Z-axis translation of acetabular shell at 6 months	RSA measured Z-axis translation of acetabular shell in mm	6 months
Secondary	X-axis rotation of the acetabular shell at 6 months	RSA measured X-axis rotation of the acetabular shell measured in degrees	6 months
Secondary	Y-axis rotation of the acetabular shell at 6 months	RSA measured Y-axis rotation of the acetabular shell measured in degrees	6 months
Secondary	Z-axis rotation of the acetabular shell at 6 months	RSA measured Z-axis rotation of the acetabular shell measured in degrees	6 months
Secondary	Maximal total point motion of the acetabular shell at 6 months	RSA measured maximal total point motion of the acetabular shell in mm	6 months
Secondary	Harris Hip Score at 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.	6 months
Secondary	HOOS Jr. Score at 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.	6 months
Secondary	FJS-12 at 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.	6 months
Secondary	RSA measured cup subsidence at 1 year	RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell	1 year
Secondary	X-axis translation of acetabular shell at 1 year	RSA measured X-axis translation of acetabular shell in mm	1 year
Secondary	Z-axis translation of acetabular shell at 1 year	RSA measured Z-axis translation of acetabular shell in mm	1 year
Secondary	X-axis rotation of the acetabular shell at 1 year	RSA measured X-axis rotation of the acetabular shell measured in degrees	1 year
Secondary	Y-axis rotation of the acetabular shell at 1 year	RSA measured Y-axis rotation of the acetabular shell measured in degrees	1 year
Secondary	Z-axis rotation of the acetabular shell at 1 year	RSA measured Z-axis rotation of the acetabular shell measured in degrees	1 year
Secondary	Maximal total point motion of the acetabular shell at 1 year	RSA measured maximal total point motion of the acetabular shell in mm	1 year
Secondary	Harris Hip Score at 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.	1 year
Secondary	HOOS Jr. Score at 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.	1 year
Secondary	FJS-12 at 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.	1 year
Secondary	X-axis translation of acetabular shell at 2 years	RSA measured X-axis translation of acetabular shell in mm	2 years
Secondary	Z-axis translation of acetabular shell at 2 years	RSA measured Z-axis translation of acetabular shell in mm	2 years
Secondary	X-axis rotation of the acetabular shell at 2 years	RSA measured X-axis rotation of the acetabular shell measured in degrees	2 years
Secondary	Y-axis rotation of the acetabular shell at 2 years	RSA measured Y-axis rotation of the acetabular shell measured in degrees	2 years
Secondary	Z-axis rotation of the acetabular shell at 2 years	RSA measured Z-axis rotation of the acetabular shell measured in degrees	2 years
Secondary	Maximal total point motion of the acetabular shell at 2 years	RSA measured maximal total point motion of the acetabular shell in mm	2 years
Secondary	Harris Hip Score at 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.	2 years
Secondary	HOOS Jr. Score at 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.	2 years
Secondary	FJS-12 at 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.	2 years
Secondary	Linear head penetration at 1 year	Amount of linear head penetration compared to baseline (6 weeks) measured in mm	1 year
Secondary	Linear head penetration at 2 years	Amount of linear head penetration compared to baseline (6 weeks) measured in mm	2 years