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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47672
Enrollment
30
Registered
2017-11-02
Start date
2018-02-19
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

joint wear Muscle weakness

Interventions

None listed

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
- Total score on the KOOS questionnaire

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)