MDR - PMCF Study for Taperloc Complete Stems

Last updated: March 10, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Taperloc Complete Stem

Clinical Study ID

NCT04028687
MDRG2017-89MS-39H
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 -TaperlocComplete stem according to a cleared indication, which includes the following:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascularnecrosis

  • Rheumatoid arthritis

  • Correction of functional deformity

  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of theproximal femur with head involvement, unmanageable by other techniques

Exclusion

Exclusion Criteria:

  • Off-label use

  • Infection

  • Sepsis

  • Osteomyelitis

  • Uncooperative patient or patient with neurologic disorders who are incapable offollowing 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 onroentgenogram

  • 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 forproper informed consent

Study Design

Total Participants: 820
Treatment Group(s): 1
Primary Treatment: Taperloc Complete Stem
Phase:
Study Start date:
February 13, 2020
Estimated Completion Date:
February 12, 2032

Study 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

Connect with a study center

  • Orthopaedic Institute of Henderson

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Texas Health Physicians Group

    Plano, Texas 75243
    United States

    Active - Recruiting

  • Proliance Orthopaedics and Sports Medicine

    Bellevue, Washington 98004
    United States

    Site Not Available

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