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Completed

NCT Number: NCT00962013

Restoration® Modular Revision Hip System Post Market Study

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

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Key information

Conditions

Arthroplasty, Replacement, Hip

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Specialty Institute, Orange, California, United States

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About this study

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates for cementless revision of a failed femoral prosthesis.
  • Patients willing to sign the informed consent.
  • Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
  • Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Exclusion criteria

  • Patients with ongoing infection.
  • Patients who are severely immunocompromised.
  • Patients who are prisoners.

Treatment and study plan

Restoration® Modular Revision Hip System

Device

Restoration® Modular Revision System

Primary outcomes

  1. Stem Survivorship (%)

    Time frame: 5 years

    Failure is defined by stem revision for any cause.

  2. Femoral Stem Fracture

    Time frame: 5 years

Secondary outcomes

  1. Radiographic Stability

    Time frame: 5 years

    Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.

  2. Harris Hip Score

    Time frame: pre-op and 5 years

    Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.

    90 - 100 = excellent

    80 - 89 = good

    70 - 79 = fair

    0 - 69 = poor

  3. SF-36 Health Status Survey: Role - Physical

    Time frame: pre-op, 2 year and 5 year

    Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:

    The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health

    This Secondary Outcome Measure is focused on the "Role-Physical" score.

  4. Post-surgery Femoral Crack/Fracture and Subsidence Rate

    Time frame: Post-op to 5 years

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

A Prospective Open-Label Evaluation of the Restoration® Modular System

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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