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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Mississippi Sports Medicine and Orthopaedic Center
ClinicalTrials.gov Identifier:
NCT01656694
First received: August 1, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoarthritis
Unicompartmental Knee Arthroscopy
Device: DePuy Sigma HP Partial Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement

Resource links provided by NLM:


Further study details as provided by Mississippi Sports Medicine and Orthopaedic Center:

Primary Outcome Measures:
  • Five-Year Survivorship [ Time Frame: Five Years Post-Op ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship [ Time Frame: Two Years and Five Years Post-Op ] [ Designated as safety issue: No ]

    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.


  • Functional Outcomes [ Time Frame: Five Years Post-Op ] [ Designated as safety issue: No ]
    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.

  • Radiographic Outcomes [ Time Frame: Pre-Operatively, Two and Five-Year Post-Op ] [ Designated as safety issue: No ]
    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.

  • Adverse Advents [ Time Frame: Post-Operatively ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Since the first Sigma® HP Partial Knee System was introduced at MSMOC, over 1,000 have been implanted in patients by the investigators of this study. The population used for this study was the first patients of our clinic to receive this particular prosthesis. The first replacement was implanted on August 21, 2008. By October 31, 2009, 300 patients had received the Sigma® HP replacement. These 300 patients will be the subject population whose data will be analyzed for the study upon their consent.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656694

Locations
United States, Mississippi
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States, 39202
Sponsors and Collaborators
Mississippi Sports Medicine and Orthopaedic Center
DePuy Orthopaedics
Investigators
Principal Investigator: Jeff D Almand, MD Mississippi Sports Medicine and Orthopaedic Center
  More Information

No publications provided

Responsible Party: Mississippi Sports Medicine and Orthopaedic Center
ClinicalTrials.gov Identifier: NCT01656694     History of Changes
Other Study ID Numbers: 11018
Study First Received: August 1, 2012
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mississippi Sports Medicine and Orthopaedic Center:
Osteoarthritis
Knee
Replacement
Unicompartmental
DePuy
Sigma HP

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014