Observational cohort study to assess the association between mitochondrial function and recovery after a primary total knee arthroplasty in the elderly.

Completed

Conditions: joint wear
10023213
Muscle weakness

Registration Number: NL-OMON47672

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Male or female of 60 years of age or older.
2. Indication for an unilateral, primary total knee arthroplasty, due to moderate to severe osteoarthritis of the knee joint (grade 3 * 4 on the Kellgren and Lawrence scale).
3. Formerly able to walk independently.
4. Signed informed consent prior to any study-mandated procedure.
5. Willingness to perform the at home measurements (Withings Body and Theripear).
6. Able to use a smart phone (iPhone or similar).

Exclusion Criteria

1. History of a performed arthroplasty of the lower extremities within 12 months before study enrollment and having planned any arthroplasty of the lower extremities within 12 months after study enrollment.
2. History (within 3 months before screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
3. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
4. Underlying chronic disease, which, in the opinion of the investigator would interfere with study participation or the validity of the measurements.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Total score on the KOOS questionnaire</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time in seconds to complete the TUG test<br /><br>- Daily activity (in steps per day), measured continuous with Withings<br /><br>smartwatch<br /><br>- Skeletal muscle mass (in kg/m2), measured weekly by Withings Body smart scale<br /><br>- Quadriceps strength (in kg), measured by the CITEC hand-held dynamometer<br /><br>- Maximal grip strength (in kg), measured by the Jamar dynamometer<br /><br>- Maximal grip strength (in kg), measured at home by the Theripear</p><br>