The objective of this study is to determine the association between mitochondrial function (activity and protein abundance of electron transport chain complexes I, II, III, IV and V) before TKA and change in KOOS score before versus 6 + 12 months…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Total score on the KOOS questionnaire
Secondary outcome
- 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
Background summary
Sarcopenia is an age-related decline in muscle mass and thought to be
accelerated by mitochondrial dysfunction. In a study in patients receiving
surgery for a hip fracture, 40% of patients were identified as sarcopenic and
in muscle tissue taken during surgery sarcopenia was correlated to a lower
mitochondrial function. Sarcopenia is equally prevalent in patients who receive
a total knee arthroplasty (TKA) for osteoarthritis . It is known that
sarcopenia has a detrimental effect on functional recovery after surgery and
due to the relationship between sarcopenia and mitochondrial dysfunction, there
might be a rationale to identify and treat mitochondrial dysfunction in
patients planned for a TKA. However, the effect of mitochondrial function on
the recovery after a TKA is not known and thus it cannot be stated that
treating mitochondrial dysfunction will be beneficial for the recovery.
Study objective
The objective of this study is to determine the association between
mitochondrial function (activity and protein abundance of electron transport
chain complexes I, II, III, IV and V) before TKA and change in KOOS score
before versus 6 + 12 months after TKA.
Study design
This is an observational cohort study to assess the relationship between
mitochondrial function and recovery after a primary total knee arthroplasty in
the elderly.
Study burden and risks
The benefits of this study are to potentially gain a pre-operative prognostic
marker for the recovery after a TKA and real-time information on the recovery
by use of activity, bioimpedance and grip strength measurements at home, which
offers the surgeon a chance to intervene with intensified physical therapy if
necessary. The burden for the patient consists of using the at home devices for
6 months after the TKA. The additional muscle sample taken during the surgery
is not expected to yield any adverse effect on the recovery process. The
questionnaires and other objective and functional outcome measures will be
performed during the planned outpatient clinic visits.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61972.056.17 |