Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
rehabilitation, total knee arthroplasty, range of motion, continuous passive motion, controlled active motion, postoperative physical therapy
Brief summary
The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.
Detailed description
The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.
Interventions
standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
OTHERcontrolled active motion (CAM I)
Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
OTHERcontrolled active motion (CAM II)
Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.
Sponsors
University of Rostock
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with knee osteoarthritis and scheduled for primary TKA * age: 50-80
Exclusion criteria
* BMI \> 40 * musculoskeletal and neurological disorders that limit physical function * any planned further joint surgery within 6 months * substantial pain or functional limitation which make the patients unable to perform study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| range of motion | change from baseline (before surgery) to discharge (9 days post surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| joint position sense | change from baseline (before surgery) to discharge (9 days after surgery) | — |
| motor function | change from baseline (before surgery) to discharge (9 days after surgery) | stair climbing test, timed up and go test |
| cognitive functioning | change from baseline (before surgery) to discharge (9 days after surgery) | — |
| physical activity | change from baseline (before surgery) to discharge (9 days after surgery) | over a period of 7 days using the activPAL activity recording system. |
| neuromuscular function | change from baseline (before surgery) to discharge (9 days after surgery) | — |
| swelling | change from baseline (before surgery) to discharge (9 days after surgery) | — |
| length of hospital stay | change from baseline (before surgery) to discharge (9 days after surgery) | — |
| quality of life | change from baseline (before surgery) to discharge (9 days after surgery) | 36-item Short Form Health Survey (SF-36) |
| pain | change from baseline (before surgery) to discharge (9 days after surgery) | visual analogue scale (VAS) |
Countries
Germany
Outcome results
None listed