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In Vivo Determination of 3D Patellofemoral Mechanics (Patella)

2019년 10월 17일 업데이트: Richard Komistek, The University of Tennessee, Knoxville
This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Colorado
      • Denver, Colorado, 미국, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, 미국, 80210
        • Colorado Joint Replacement
    • Tennessee
      • Knoxville, Tennessee, 미국, 37996
        • Perkins Hall
      • Knoxville, Tennessee, 미국, 37996
        • Science and Engineering Research Facility

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.

설명

Inclusion Criteria:

  1. Patients must be at least six months post-operative.
  2. Potential subjects will have a body weight of less than 250 lbs.
  3. Candidates must have an AKS score >70 post-operatively.
  4. Patients must have passive flexion of at least 100.
  5. Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
  6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria:

  1. Pregnant females.
  2. Subjects not meeting study requirements.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 전용
  • 시간 관점: 회고전

코호트 및 개입

그룹/코호트
개입 / 치료
Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
장치: Subjects implanted with DePuy LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
장치: Subjects implanted with DePuy Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Control
Subjects with normal knees

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patella Flexion With Respect to Femur
기간: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Rotation With Respect to Femur
기간: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Tilt With Respect to Femur
기간: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Medial Patella Contact Point Translation
기간: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Lateral Patella Contact Point Translation
기간: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The University of Tennessee, Knoxville

협력자

DePuy Orthopaedics

수사관

  • 수석 연구원: Richard D. Komistek, Ph D, The University of Tennessee
  • 수석 연구원: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 2월 1일

기본 완료 (실제)

2011년 9월 1일

연구 완료 (실제)

2011년 9월 1일

연구 등록 날짜

최초 제출

2011년 2월 3일

QC 기준을 충족하는 최초 제출

2011년 2월 4일

처음 게시됨 (추정)

2011년 2월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 17일

마지막으로 확인됨

2019년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 10035/IIS-000126
  • R011373372 (기타 보조금/기금 번호: DePuy Orthopaedics)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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