Osteo Arthritis Knee
Conditions
Keywords
cryotherapy, TKA, postoperative rehabilitation, pain, recovery, opioid
Brief summary
The aim of this study was to investigate whether computer-assisted cryotherapy is effective in reducing postoperative pain and analgesics consumption, next to improving functional outcome and patient satisfaction after total knee arthroplasty (TKA). The hypothesis is that computer-assisted cryotherapy has positive effects on postoperative pain after TKA. For this purpose a single-centre non-blinded trial was designed where two groups of patients were observed, a cold (cryotherapy) C-group and a regular (control) R-group. Depended on the week they were operated patients received either usual care (R-group) or computed-assesed- cryotherapy (odd or even week; week-on/week-off principle). Patients in the C-group received next to usual postoperative care computer-assisted cryotherapy for several hours a day during the first seven postoperative days (10-12 degrees Celcius). Primary outcome was pain, monitored with the numerical rating scale for pain. Secondary outcomes were the use of opioid escape medication, function and swelling, monitored by active range of motion, timed up and go test and circumference measurements; several patient-reported outcome measures (short term 2 and 6 weeks; and longer term 6 and 12 months postoperative); and patient satisfaction, monitored by the numerical rating scale for satisfaction.
Detailed description
The study was conducted at the Orthopaedic Surgery Department of Martini Hospital, a teaching hospital in the Netherlands. All participants gave signed informed consent before participation. Patients with end-stage OA over the age of 18 who were scheduled for a TKA were invited to participate in this study. Exclusion criteria were rheumatoid arthritis, skin or other infections, vascular disease, other comorbidities on which cooling may have a negative effect, and strong preference for one of the treatment options. Patients were randomised into one of the two groups by a week-on/week-off principle. Patients who underwent TKA surgery in an even week received additional postoperative cryotherapy (C-group), those who had the surgery in an odd week received usual postoperative care (R-group). Surgery dates were scheduled in the usual way by the planning department of the hospital. Two weeks before surgery, patients were informed by phone as to which group they were assigned to. Both groups received the usual rapid recovery (RR) care and rehabilitation program, consisting of local infiltration analgesia during surgery, compressive bandaging for 24 h after surgery, and full weight-bearing mobilisation and active range of motion exercises starting on the day of surgery. Antibiotics were given preoperatively and postoperatively. All patients received thromboembolic prophylaxis for a period of six weeks. The Smith & Nephew (Memphis, USA) posterior stabilized (PS) GENESIS II total knee system was used for the TKA. For the CAC in the C-group, the ZAMAR ZHC-MG665A (ZAMAR, Vrsar, Croatia) was used during hospitalisation and the smaller CAC system ZAMAR ZT Cube (ZAMAR, Vrsar, Croatia) for the home situation. The CAC system was delivered to the patient's home before the day of the surgery. Both models had a touchscreen with pre-set programs, with parameters as shown in the cooling schedule. All patients received a personal cooling brace, the ZAMAR Wrap, which transferred cold onto the skin and deep tissue around the knee. Patients in the C-group were instructed to cool the operated knee during the first seven postoperative days. The schedule they received was based on a schedule used by Thijs et al. Patients were allowed to deviate from this schedule, but were asked to document the actual cooling time and temperature in a log.
Interventions
DEVICEComputed-assisted-cryotherapy
cryotherapy device
Sponsors
Martini Hospital Groningen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for a primary TKA or UKA in the Martini Hospital. * Age ≥ 18 years
Exclusion criteria
* skin (or other) infections * rheumatoid arthritis * vascular disease * having a strong preference for one of the two treatment options
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) pain score in rest | assessed at 6 weeks postoperative | range 0-10, where a higher score indicates more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) pain scores while loading | at baseline, daily during the first 7 days, after 2 and 6 weeks, and 6 and 12 months postoperative | range 0-10, where a higher score indicates more pain |
| Opioid use | daily during the first week after surgery | The amount of opioid use in case of excessive pain |
| active Range of Motion | at baseline and at 6 weeks postoperative | in degrees |
| Timed Up and Go | at baseline and at 6 weeks postoperative | In seconds. Measure of functional mobility. |
| Knee circumference | at baseline and at 6 weeks postoperative | in centimeters |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire | preoperative and 2 and 6 weeks postoperative | Without the sports and recreation domain. Range 0-100, where a higher score indicates less symptoms. |
| Work, Osteoarthritis en joint-Replacement Questionnaire (WORQ) | preoperative and 2 and 6 weeks postoperative | Measure of work ability (functioning). Range 0-100, where a higher score indicates less functional limitations. |
| Numeric rating scale (NRS) pain score in rest | at baseline, daily during the first 7 days, after 2 weeks, and 6 and 12 months postoperative | range 0-10, where a higher score indicates more pain |
| Oxford knee scores | preoperative and 6 and 12 months postoperative | Range 0-48, where a higher score indicates less symptoms. |
| KOOS-PS scores (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form) | preoperative, and 6 and 12 months postoperative | Range 0-100, where a higher score indicates less symptoms |
| Numeric rating scale (NRS) satisfaction | 2 and 6 weeks postoperative, and 6 and 12 months postoperative | patient's satisfaction with the outcome after surgery at that time point, range 0-10, where a higher score indicates more satisfaction |
| anchor question: patient perceived change in pain | 6 and 12 months postoperative | the degree in which a patient experiences an improvement in pain compared to baseline (7 point Likert scale: much worse, worse, slightly worse, no change, slightly better, better, much better) |
| anchor question: patient perceived change in functioning | 6 and 12 months postoperative | the degree in which a patient experiences an improvement in functioning compared to baseline (7 point Likert scale: much worse, worse, slightly worse, no change, slightly better, better, much better) |
| Numeric rating scal (NRS) satisfaction cryotherapy | 1 week postoperative | Only for the patients who used the Computer-assisted-cryotherapy device: patient's satisfaction with cryotherapy. Range 0-10, where a higher score indicates more satisfaction. |
| Complications/Serious adverse events | from baseline until 12 months postoperative | Keep record of the complications that occurred |
| EuroQol 5D (EQ5D) - 5 point Likert scale | preoperative and 6 and 12 months postoperative | Index score (0-1, closer to 1 indicates better health related quality of life); visual Analogue Scale scale about the self-perceived health status (0-100, higher indicates better self-perceived health status). |
Countries
Netherlands
Outcome results
None listed