Overview

This trial is active, not recruiting.

Conditions osteoarthritis, unicompartmental knee arthroscopy
Treatment depuy sigma hp partial knee
Sponsor Mississippi Sports Medicine and Orthopaedic Center
Collaborator DePuy Orthopaedics
Start date August 2012
End date December 2015
Trial size 300 participants
Trial identifier NCT01656694, 11018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Measure
Five-Year Survivorship
time frame: Five Years Post-Op

Secondary Outcomes

Measure
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
time frame: Two Years and Five Years Post-Op
Functional Outcomes
time frame: Five Years Post-Op
Radiographic Outcomes
time frame: Pre-Operatively, Two and Five-Year Post-Op
Adverse Advents
time frame: Post-Operatively

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
Principal investigator Jeff D Almand, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Mississippi Sports Medicine and Orthopaedic Center.