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Completed

NCT Number: NCT01656694

A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis

This study will be conducted to assess the survivorship of a particular prosthesis used in unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed with isolated medial or lateral compartmental arthritis and have failed conservative treatment. The patients received a unicompartmental knee replacement using the Sigma® HP Partial Knee System.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Unicompartmental Knee Arthroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202, United States

About this study

This study is an epidemiological Level IV-Case Series clinical study that will study the survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October 31, 2009 will be available to include in the study. Data will be collected preoperatively, intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years, and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up visits. Other data, including functional outcomes, radiographic outcomes, and wear will be analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years after their surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient over the age of 18
  • Diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee joint
  • Must have failed conservative treatment and received a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
  • Must have received the Sigma® HP Partial Knee System.
  • Must have received the surgery from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
  • Must be willing to provide written consent to participate in the study.
  • Subjects who do not have the legal capacity to consent may be enrolled in the study by a Legally Authorized Representative (LAR). The LAR must provide verification that they have the legal authority to represent the subject.

Exclusion criteria

  • Did not receive a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
  • Did not receive a unicompartmental knee arthroplasty using the Sigma® HP Partial Knee.
  • Did not receive their unicompartmental knee replacement from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
  • Subjects lost to follow-up for any reason including, but not limited to: refusal to consent, death, or geographic isolation will also be excluded from the study.

Treatment and study plan

DePuy Sigma HP Partial Knee

Device

Primary outcomes

  1. Five-Year Survivorship

    Time frame: Five Years Post-Op

    The primary endpoint of the study is to determine the five-year survivorship of the Sigma® HP Partial Knee System with failure defined as revision for any reason.

Secondary outcomes

  1. Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship

    Time frame: Two Years and Five Years Post-Op

    One secondary endpoint of the study is to determine the five-year survivorship of the prosthesis with alternately defining failure as: failure of implant, failure secondary to infection, failure secondary to progression of arthritis, failure secondary to periprosthetic fracture.

    We also want to determine the two-year survivorship with failure defined as revision for any reason.

  2. Functional Outcomes

    Time frame: Five Years Post-Op

    Another secondary endpoint of the study is to analyze the functional outcomes for five-year data based on the Knee Society score and the KOOS (Knee Injury and Osteoarthritis Outcome Score) score, reported as changes from the pre-operative score. By using both rating systems, an appropriate evaluation of the functional outcome of the surgery should be obtained.

  3. Radiographic Outcomes

    Time frame: Pre-Operatively, Two and Five-Year Post-Op

    Another secondary endpoint of the study is to determine the radiographic outcomes based upon the radiographic assessment using the Knee Society scoring system, reported as changes from the pre-operative assessment. Additionally, we want to radiographically assess lucencies at the bone cement and implant cement interface to measure wear and loosening of the prosthesis.

  4. Adverse Advents

    Time frame: Post-Operatively

    We also want to examine the type and frequency of adverse events as a secondary endpoint of the study. Safety will be evaluated with summary of adverse events.

Sponsors and collaborators

Lead sponsor

Mississippi Sports Medicine and Orthopaedic Center

Other

Collaborators

  • DePuy Orthopaedics

Registry information

Official study title

Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 3, 2012
Registry last updated
Mar 22, 2018

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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