Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion.
Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term.
The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icepacks | Active Comparator | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery. |
|
| Cryocompression | Experimental | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Device | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare post-operative pain between the intervention and the control group | Pain measured on numeric rating scale (NRS) at 48 hours postoperatively. 0 means no pain and 10 means severe pain. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| To compare post-operative pain during the study | Pain measured on numeric rating scale (NRS), preoperatively, and postoperatively at 1, 3, and 9 months. 0 means no pain and 10 means severe pain. | 1, 3, and 9 months |
| To compare the evolution of joint function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des Cèdres | Recruiting | Échirolles | 38130 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Game Ready | Device | Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery. |
|
Function assessed using the short version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months. It comprises five pain items (0-20), two stiffness items (0-8), and seventeen physical function items (0-68), using a 0-4 Likert scale (None to Extreme). The total score ranges from 0 (best) to 96 (worst). |
| preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months |
| To compare the evolution of mobility | Range of motion, including knee flexion and extension, measured using a goniometer, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months | preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months |
| To compare the incidence of oedema | Ipsilateral knee circumference and comparing it to the contralateral side, preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months | preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month |
| To compare wound healing | Qualitative assessment: preoperatively, postoperatively assessed at 48 hours and at 1, and 3 months | preoperatively, postoperatively at 48 hours and at 1, and 3 months |
| To compare blood loss | Blood hemoglobin levels, preoperatively, and postoperatively at 24 hours, and 1 week | preoperatively, and postoperatively at 24 hours, and 1 week |
| To compare pain killer consumption | Number, type and dosage of pain killers consumed at 48 hours, and at 1, 3 and 9 months | at 48 hours, and at 1, 3 and 9 months |
| To compare quality of sleep | Using Pittsburgh Sleep Quality Index (PSQI) preoperatively, at 48 hours, and at 1, 3 and 9 months. This score involves summing seven component scores, each ranging from 0 (no difficulty) to 3 (severe difficulty), to get a global score from 0 to 21, with higher scores indicating poorer sleep quality, and a score > 5 generally suggesting significant sleep problems. | preoperatively, at 48 hours, and at 1, 3 and 9 months |
| To compare safety of postoperative procedures | Incidence and severity of all adverse events related to the procedures | at 48 hours, and at 1, 3 and 9 months |