Continuum™ Metal Bearing System in Total Hip Arthroplasty

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03382652

Collaborator

(none)

Enrollment

Locations

227.7

Anticipated Duration (Months)

28.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Avascular Necrosis Osteoarthritis Inflammatory Arthritis Post-traumatic; Arthrosis Total Hip Arthroplasty

Detailed Description

The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life.

In total, 3 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of investigators. A total number of 100 subjects will be included in the study. It is anticipated that each clinical site will enroll 10 to 45 eligible study subjects, who have provided written informed consent.

Study Design

Study Type:

Observational

Actual Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Continuum™ Metal Bearing System in Total Hip Arthroplasty- A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

Actual Study Start Date :

Feb 9, 2011

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Feb 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Patients who received the Continuum Metal on Metal System Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System

Outcome Measures

Primary Outcome Measures

The primary endpoint for this study is implant survival at 10 years. [10 years]
The primary endpoint for this study is implant survival, which is assessed by the number of revisions and calculated using the Kaplan-Meier Survival Estimation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is 18 to 75 years of age, inclusive.
Patient is skeletally mature.
Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
Avascular necrosis (AVN) Osteoarthritis (OA)
Inflammatory arthritis (i.e. Rheumatoid arthritis)
Post-traumatic arthritis
Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
Patient has a Harris Hip Score <70 in the affected hip
Patient is willing and able to provide written informed consent.
Patient is willing and able to cooperate in the required post-operative therapy.
Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.

Exclusion Criteria:

The patient is:
A prisoner
Mentally incompetent or unable to understand what participation in the study entails
A known alcohol or drug abuser
Anticipated to be non-compliant.
The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
The patient is known to be pregnant.
The patient is unwilling or unable to give consent, or to comply with the follow-up program.
The patient has received an investigational drug or device within the previous 6 months.
The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
The patient has known local bone tumors and/or cysts in the operative hip.
The patient has a known allergic reaction to one or more of the implanted material.
The patient is Grade III obese with a Body Mass Index (BMI) ≥ 40.
The patient has osteoradionecrosis in the affected hip joint
Kidney insufficiency (Kidney insufficiency will be determined based on eGFR value.

See Blood Analysis Report CRF for details)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Davids Medical Center	Austin	Texas	United States	78705
2	Jokilaakson terveys oy	Jämsä		Finland
3	Hospital District of Southwest Finland	Turku		Finland	FI-00029 HUS