MDR - PMCF Study for Taperloc Complete Stems

Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Study Overview

• Status: Recruiting
• Conditions: Hip Pain Chronic; Hip Fractures; Hip Injuries; Hip Disease; Hip Arthritis
• Intervention / Treatment: Device: Taperloc Complete Stem

Detailed Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

• Study Type: Observational
• Enrollment (Estimated): 820

Contacts and Locations

• Study Contact: Name: Abigail Fishel; Phone Number: 574-526-1765; Email: Abigail.Fishel@zimmerbiomet.com
• Study Contact Backup: Name: Lynsey Boyle; Phone Number: 412-552-7111; Email: lynsey.boyle@zimmerbiomet.com

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Withdrawn
      • Orthopaedic Institute of Henderson
  • Texas
    • Plano, Texas, United States, 75243
      • Recruiting
      • Texas Health Physicians Group
      • Principal Investigator: Roger Emerson, MD
      • Sub-Investigator: Kwame Ennin, MD
      • Contact: Shuvie Dasgupta; Phone Number: 972-981-7114; Email: shuvalaxmidasgupta@texashealth.org
  • Washington
    • Bellevue, Washington, United States, 98004
      • Withdrawn
      • Proliance Orthopaedics and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.

Description

Inclusion Criteria:

• Patient must be 18 years of age or older and skeletally mature
• Patient must be willing and able to sign IRB approved informed consent
• Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

Exclusion Criteria:

• Off-label use
• Infection
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy, or neuromuscular disease
• Patient is known to be pregnant or nursing
• Patient is a prisoner
• Patient is a known alcohol or drug abuser
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Taperloc Complete Stems; Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.	Device: Taperloc Complete Stem; Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.	The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.	Out to 10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Performance and Benefits evaluated through the Harris Hip Score	The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed.	Out to 10 Years
Device Performance and Benefits evaluated through the Oxford Hip Score	The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.	Out to 10 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): February 12, 2032
• Study Completion (Estimated): February 12, 2032

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Fractures; Hip Injuries
• Other Study ID Numbers: MDRG2017-89MS-39H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes