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

NCT03865667 | Active Not Recruiting

• 1 other identifier: 12-LJH-002G
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.

  Percentage of hips survived with no revision or replacement at 10-year.

  10 years

Secondary Outcomes (4)

• To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck at specified intervals out to 10 years follow-up.

  Time Frame: 2-5 years, 5-7 years, and 10 years

• To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores.

  Time Frame: 2-5 years, 5-7 years, and 10 years

• To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components.

  2-5 years, 5-7 years, and 10 years

• To characterize of adverse events and adverse device effects.

  2-5 years, 5-7 years, and 10 years

Study Arms (1)

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.

Device: PROFEMUR® Preserve Femoral Stem

Interventions

PROFEMUR® Preserve Femoral Stem DEVICE

Total Hip Total Hip Arthroscopy

Primary Total Hip Arthroplasty

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

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 Arthroscopy) components including acetabular shells, acetabular liners and femoral heads.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Dr. Manel Ribas

Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Manel Ribas, MD

  Hospital Universitari Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: January 15, 2019
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)