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

NCT04147559 | Enrolling By Invitation FDA Device

• 1 other identifier: 19H001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Joint Diseases

Keywords

Osteoarthritis; avascular necrosis; ankylosis; protrusio acetabuli; painful hip dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• To determine the cumulative revision rate at specified intervals out to 10 years follow-up

  10 years post-operative

• Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.

  10 years post-operative

• Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L

  10 years post-operative

• To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).

  10 years post-operative

• To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.

  10 years post-operative

Interventions

Total Hip Arthroplasty Implant DEVICE

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.

Also known as: PROFEMUR® Preserve Classic Femoral Stem

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
• Skeletally immature (less than 21 years of age) at time of implantation
• Has or had an overt infection at the time of implantation
• Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
• 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
• Has or had neuropathic joints
• Has or had hepatitis or HIV infection
• Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
• Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
• Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Unwilling or unable to sign the Informed Consent document
• Has documented substance abuse issue
• Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Currently incarcerated or has impending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (2)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

HCA Research Institute, OrthoONE at Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis; Ankylosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Joseph Assini, MD

  OrthoOne at Swedish Medical Center

  PRINCIPAL INVESTIGATOR

• Judd Cummings, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 1, 2019
• Study Start: October 21, 2020
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)