Clinical trial NCT01656694: A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
Official title: Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Unicompartmental Knee Arthroscopy
Keywords: Osteoarthritis
Knee
Replacement
Unicompartmental
DePuy
Sigma HP
Lead sponsor: Mississippi Sports Medicine and Orthopaedic Center
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2012-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Five-Year Survivorship
timeFrame: Five Years Post-Op
Secondary outcomes:
measure: Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
timeFrame: Two Years and Five Years Post-Op
measure: Functional Outcomes
timeFrame: Five Years Post-Op
measure: Radiographic Outcomes
timeFrame: Pre-Operatively, Two and Five-Year Post-Op
measure: Adverse Advents
timeFrame: Post-Operatively
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center
state: Mississippi
Study officials:
affiliation: Mississippi Sports Medicine and Orthopaedic Center
name: Jeff D Almand, MD
role: PRINCIPAL_INVESTIGATOR
References: