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

NCT ID: NCT03865667

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2032-01-01

Brief Summary

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Conditions

Joint Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary Total Hip Arthroplasty

Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroplasty) components including acetabular shells, acetabular liners and femoral heads.

PROFEMUR® Preserve Femoral Stem

Intervention Type: DEVICE

Total Hip Total Hip Arthroscopy

Interventions

PROFEMUR® Preserve Femoral Stem

Total Hip Total Hip Arthroscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Has undergone primary Total Hip Arthroscopy for any of the following:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;lnflammatory degenerative joint disease such as rheumatoid arthritis; or
• Correction of functional deformity;
• Subject is implanted with the PROFEMUR® Preserve Femoral Stem(s) and cobalt-chromium Modular Neck;
• Subject is willing and able to complete required study visits or assessments through the 10 year postoperative follow-up schedule;
• Subject is implanted with WMT or MPO head, cup and liner.

Exclusion Criteria

Previously implanted subjects who had undergone revision of any Total Hip Arthroscopy component including the PROFEMUR® Preserve Femoral Stem(s) or, cobalt-chromium Modular Neck will also be eligible to be considered for this study.

Subjects will be excluded if they meet any of the following criteria:

• Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
• Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
• Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
• Subjects have or had an overt infection at the time of implantation;
• Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
• Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation;
• Subjects have 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;
• Subject has neuropathic joints;
• Subject has hepatitis or HIV infection;
• Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
• Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol;
• Subjects unwilling or unable to sign the Informed Consent document;
• Subjects with documented substance abuse issues;
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study;
• Subjects who are incarcerated or have pending incarceration.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manel Ribas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Dexeus

Locations

Dr. Manel Ribas

Barcelona, , Spain

Countries

Spain

Other Identifiers

12-LJH-002G

Identifier Type: -

Identifier Source: org_study_id