Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring® knee implant for load reduction - The SOAR protocol

Jack Farr, Dennis Crawford, David R. Diduch, Elizabeth A. Arendt, C. Benjamin Ma, Chuan Silvia Li

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.

Original languageEnglish (US)
Pages (from-to)161-173
Number of pages13
JournalJournal of Long-Term Effects of Medical Implants
Volume23
Issue number2-3
DOIs
StatePublished - 2013

Fingerprint

Knee Osteoarthritis
Knee
Osteoarthritis
Safety
Labels
Pain
Population

Keywords

  • Knee
  • Osteoarthritis
  • Study protocol

ASJC Scopus subject areas

  • Biomedical Engineering
  • Dentistry(all)

Cite this

Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring® knee implant for load reduction - The SOAR protocol. / Farr, Jack; Crawford, Dennis; Diduch, David R.; Arendt, Elizabeth A.; Ma, C. Benjamin; Li, Chuan Silvia.

In: Journal of Long-Term Effects of Medical Implants, Vol. 23, No. 2-3, 2013, p. 161-173.

Research output: Contribution to journalArticle

@article{f2a571b80f6742cfabb82d74e93652cc,
title = "Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring{\circledR} knee implant for load reduction - The SOAR protocol",
abstract = "The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring{\circledR} Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20{\%} compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.",
keywords = "Knee, Osteoarthritis, Study protocol",
author = "Jack Farr and Dennis Crawford and Diduch, {David R.} and Arendt, {Elizabeth A.} and Ma, {C. Benjamin} and Li, {Chuan Silvia}",
year = "2013",
doi = "10.1615/JLongTermEffMedImplants.2013010140",
language = "English (US)",
volume = "23",
pages = "161--173",
journal = "Journal of Long-Term Effects of Medical Implants",
issn = "1050-6934",
publisher = "Begell House Inc.",
number = "2-3",

}

TY - JOUR

T1 - Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring® knee implant for load reduction - The SOAR protocol

AU - Farr, Jack

AU - Crawford, Dennis

AU - Diduch, David R.

AU - Arendt, Elizabeth A.

AU - Ma, C. Benjamin

AU - Li, Chuan Silvia

PY - 2013

Y1 - 2013

N2 - The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.

AB - The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.

KW - Knee

KW - Osteoarthritis

KW - Study protocol

UR - http://www.scopus.com/inward/record.url?scp=84890511850&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84890511850&partnerID=8YFLogxK

U2 - 10.1615/JLongTermEffMedImplants.2013010140

DO - 10.1615/JLongTermEffMedImplants.2013010140

M3 - Article

C2 - 24579856

AN - SCOPUS:84890511850

VL - 23

SP - 161

EP - 173

JO - Journal of Long-Term Effects of Medical Implants

JF - Journal of Long-Term Effects of Medical Implants

SN - 1050-6934

IS - 2-3

ER -