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Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02983929
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Timothée Gillot, Centre Hospitalier Durécu Lavoisier

Tracking Information
First Submitted Date November 29, 2016
First Posted Date December 6, 2016
Last Update Posted Date December 8, 2016
Study Start Date January 2007
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2016)
  • Body Mass Index [ Time Frame: 2 Month ]
  • Range Of Motion of the Knee [ Time Frame: 2 Month ]
    The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant.
  • Age [ Time Frame: 2 Month ]
  • Mansat Score [ Time Frame: 2 Month ]
    This score is a composite score recommended by the French Authority of Health.
Original Primary Outcome Measures
 (submitted: December 2, 2016)
  • Body Mass Index [ Time Frame: 2 Month ]
  • Range Of Motion of the Knee [ Time Frame: 2 Month ]
    We wil report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee.
  • Age [ Time Frame: 2 Month ]
  • Mansat Score [ Time Frame: 2 Month ]
    This score is a composite score validated and recommanded by the French Autority of Health.
Change History Complete list of historical versions of study NCT02983929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 7, 2016)
Length of stay [ Time Frame: 2 month ]
The investigators will report the length of stay in the rehabilitation clinic for each participant.
Original Secondary Outcome Measures
 (submitted: December 2, 2016)
Length of stay [ Time Frame: 2 month ]
We will report for each patient the lenght of stay in the rehabilitation clinic.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index
Official Title Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study
Brief Summary

The main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. It is a retrospective, comparative study

The secondary purposes are to explore the links between length of stay and short-term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Not Provided
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men and Women admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic.
Condition
  • Total Knee Arthroplasty
  • Body Mass Index
  • Rehabilitation
Intervention Procedure: Rehabilitation after total knee arthroplasty
All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.
Study Groups/Cohorts
  • BMI <30 kg.m-2
    Patients with a BMI inferior to the obesity limit defined by the World Health Organization.
    Intervention: Procedure: Rehabilitation after total knee arthroplasty
  • BMI >30 kg.m-2
    Patients with a BMI superior to the obesity limit defined by the World Health Organization.
    Intervention: Procedure: Rehabilitation after total knee arthroplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2016)
244
Original Actual Enrollment Same as current
Actual Study Completion Date November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic during the january 2007/October 2016 period

Exclusion Criteria:

  • Uncompleted case file or case file anterior to 2007 ;
  • Inter-current orthopedic complication ;
  • Evolutive or inter-current pathology written in the case-file (neurologic affection, etc...).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02983929
Other Study ID Numbers MK1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Timothée Gillot, Centre Hospitalier Durécu Lavoisier
Study Sponsor Centre Hospitalier Durécu Lavoisier
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Durécu Lavoisier
Verification Date December 2016