Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Joint Diseases Clinical Trial

Official title:

Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04147559
• Other study ID #: 19H001
• Status: Enrolling by invitation
• Start date: October 21, 2020
• Est. completion date: November 1, 2033

Study information

• Verified date: March 2024
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: November 1, 2033
• Est. primary completion date: May 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.

2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

• inflammatory degenerative joint disease such as rheumatoid arthritis;

• correction of functional deformity 3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit 4. Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.

Exclusion Criteria:

1. Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)

2. Skeletally immature (less than 21 years of age) at time of implantation

3. Has or had an overt infection at the time of implantation

4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation

5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation

6. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable

7. Has or had neuropathic joints

8. Has or had hepatitis or HIV infection

9. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing

10. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques

11. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol

12. Unwilling or unable to sign the Informed Consent document

13. Has documented substance abuse issue

14. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

15. Currently incarcerated or has impending incarceration

16. Has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol -

Related Conditions & MeSH terms

• Joint Diseases

Intervention

Device:
• Total Hip Arthroplasty Implant
Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.

Locations

Country	Name	City	State
United States	HCA Research Institute, OrthoONE at Swedish Medical Center	Englewood	Colorado
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Component Survivorship	The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.	10 years post-operative
Secondary	To determine the cumulative revision rate at specified intervals out to 10 years follow-up	Percentage of hips that were revised or replaced at each of the intervals for Year 1, Year 3, Year 5, Year 7 and Year 10 evaluation.	10 years post-operative
Secondary	Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.	The study will be reporting the final Hip Disability and Osteoarthritis Outcome Score (HOOS) which ranges from 0 to 100 with a score of 0 indicating worst hip symptoms and 100 indicating no hip symptoms.	10 years post-operative
Secondary	Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L	EQ-5D-5L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 5 levels: no problems, slight problem, moderate problem, severe problem, inability to perform the activity. With no problems being the best outcome and inability to perform the activity being worst outcome.	10 years post-operative
Secondary	To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).	The study will be reporting forgotten joint score measures for the assessment of joint-specific patient reported outcomes. The questions focus on the patients' awareness of the implanted joint in everyday life or any unintended perception of a joint.	10 years post-operative
Secondary	To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.	The Satisfaction Survey consists of questions asked about how satisfied the patient is with the new implant.	10 years post-operative
Secondary	To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem	Radiolucencies are described around 7 zones and will be reporting the number of hips with radiolucencies present at a given zone.	10 years post-operative
Secondary	To characterize adverse events and adverse device effects	Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effects (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will also be provided.	10 years post-operative