Table 2.
Summary of outcome measures to be collected in the trial with time-points
|
Primary outcome |
Data collection instrument (unit) |
Collection time-point |
||
|---|---|---|---|---|
| Baseline | Post (days) | Post (months) | ||
| Function in daily living |
KOOS |
Pre |
14 |
3,6,12 |
|
Secondary outcome |
|
|
|
|
| KOOS - 4 subscales |
|
|
|
|
| Pain |
KOOS |
Pre |
14 |
3,6,12 |
| Symptoms |
KOOS |
Pre |
14 |
3,6,12 |
| Sport and recreation |
KOOS |
Pre |
14 |
3,6,12 |
| Quality of life |
KOOS |
Pre |
14 |
3,6,12 |
| Questionnaire |
|
|
|
|
| Global perceived effect |
GPE |
|
|
3,6,12 |
| Bilateral physical Performance |
|
|
|
|
| Knee range of motion (KneeROM) |
Goniometer (°) |
Pre |
3,14 |
3,6 |
| 30-s chair-stand test (30s CRT) |
(Number) |
Pre |
3,14 |
3,6 |
| 20-m self- and fast-paced walk test (20mWT) |
Stopwatch (s) |
Pre |
3,14 |
3,6 |
| Timed up-and-go test (TUG) |
Stopwatch (s) |
Pre |
3,14 |
3,6 |
|
Explorative outcomes |
|
|
|
|
| Mechanical muscle function |
|
|
|
|
| Maximal isometric knee strength (iMVC) |
Strain-gauge (Nm) |
Pre |
|
3,6 |
| Dynamic leg extension power |
(W) |
Pre |
|
3,6 |
| Rate of force development (RFD) |
(Nm/sec) |
Pre |
|
3,6 |
| Surface electromyography (EMG) |
Myon (mV) |
Pre |
|
3,6 |
| Force steadiness |
(Nm) |
Pre |
|
3,6 |
| Unilateral physical performance |
|
|
|
|
| 30-s single-leg knee bending (30s-KneeBend) |
(Number) |
Pre |
|
3,6 |
| Pain |
|
|
|
|
| Self-reported use of pain medication |
(Quantity) |
Pre |
1-14 |
|
| Self-reported pain (VAS) |
VAS |
Pre |
1-14 |
|
| Biopsies |
|
|
|
|
| Muscle biopsy | Prior to applying and removal of the tourniquet | |||