이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Total Knee Arthroplasty: Functional and Clinical Outcomes

2017년 4월 28일 업데이트: Duke University

Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Patients requiring primary total knee replacement
  2. Patients willing and able to comply with the follow-up visits and evaluations
  3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

  1. Patients with inflammatory arthritis
  2. Patients with diabetic neuropathy
  3. Patients unable to ambulate without the use of an assistive device prior to surgery
  4. Patients unable to stand in single limb stance on each foot prior to surgery.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
장치: Stryker
활성 비교기: Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
장치: Zimmer

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
기간: Baseline (Pre-Operative) to 6 weeks following total knee replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Baseline (Pre-Operative) to 6 weeks following total knee replacement
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
기간: Baseline (Pre-Operative) to 52 weeks following total knee replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Baseline (Pre-Operative) to 52 weeks following total knee replacement

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
기간: Baseline and 52 weeks following total knee replacement
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Baseline and 52 weeks following total knee replacement
Walking Speed at 6 Weeks Following Total Knee Replacement.
기간: 6 weeks following total knee replacement
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
6 weeks following total knee replacement

기타 결과 측정

결과 측정
측정값 설명
기간
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
기간: Baseline and 52 weeks following total knee replacement
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Baseline and 52 weeks following total knee replacement
University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
기간: 6 weeks following total knee replacement
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
6 weeks following total knee replacement
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
기간: Baseline (Pre-Operative) and 52 weeks following total knee replacement
The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Baseline (Pre-Operative) and 52 weeks following total knee replacement
Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
기간: 6 weeks and 52 weeks following total knee replacement
The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
6 weeks and 52 weeks following total knee replacement
Knee Society Score (KSS)
기간: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Sit to Stand Time
기간: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Timed Get up and go
기간: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Duke University

수사관

  • 수석 연구원: Samuel S Wellman, MD, Duke University

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

2013년 2월 1일

기본 완료 (실제)

2016년 2월 26일

연구 완료 (실제)

2016년 2월 26일

연구 등록 날짜

최초 제출

2013년 3월 12일

QC 기준을 충족하는 최초 제출

2013년 3월 12일

처음 게시됨 (추정)

2013년 3월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 28일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00043737
  • 193447 (기타 보조금/기금 번호: Stryker)

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. .

Stryker에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Azerbaijan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다