Clinical trial NCT04136431: Effects of Programmed Cryotherapy and Continuous Passive Motion After Computer-Assisted Total Knee Arthroplasty
Official title: The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Osteoarthritis Undergoing CAS-TKA
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.

Detailed description: The International Association for the Study of Pain (IASP) has proposed the definition of pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Therefore, adequate pain management and control of localized swelling and stiffness after TKA has become a priority because it is essential for improving patient satisfaction, prevention of complications, and enhancing quality of life by faster recovery. Systemic and local analgesics are the most common strategies for postoperative pain management in TKR. However, patients might experience nausea, vomiting, constipation, or respiratory failure due to opioid-related side effects, subsequently refusing to mobilize and delaying the rehabilitation program).

In addition to pain control, cryotherapy and continuous passive motion (CPM) are commonly used for TKA patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion. The application of cryotherapy after TKA has been described extensively in the literature and is part of standard care globally. However, its benefits and value remain controversial due to the disparity in practice, such as differences in clinical protocols and the type of cryotherapy application. Continuous passive motion is a motorized device, which passively moves the knee joint within a certain range of motion (ROM) to decrease analgesics requirements, reduce the incidence of deep vein thrombosis, and increase ROM. But the effects of CPM remain contentious in the literature. Although controversial, cryotherapy and CPM have been used extensively as part of the standard postoperative management protocol for TKA patients without knowing its cost-effectiveness. However, the value of combined therapy of cryotherapy and CPM remains uncertainty and unclear following CAS-TKA.

The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.

Eligibility criteria: Inclusion Criteria:

* primary and unilateral computer-assisted total knee arthroplasty

Exclusion Criteria:

* (1) patients who underwent bilateral TKAs, unicompartmental TKA or revision TKA
* (2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy
* (3) patients who were unable to response to the questionnaires.

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Postoperative day 1
measure: Numeric Rating Scale (NRS)
timeFrame: Postoperative day 4
Secondary outcomes:
measure: The short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Postoperative day 1
measure: The short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Postoperative day 4
measure: Thigh and calf circumference
timeFrame: Postoperative day 1
measure: Thigh and calf circumference
timeFrame: Postoperative day 4
measure: Range of motion of knee joints
timeFrame: Postoperative day 1
measure: Range of motion of knee joints
timeFrame: Postoperative day 4
Other outcomes:
Locations:
Study officials:
References:
citation: Chen MC, Lin CC, Ko JY, Kuo FC. The effects of immediate programmed cryotherapy and continuous passive motion in patients after computer-assisted total knee arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2020 Sep 3;15(1):379. doi: 10.1186/s13018-020-01924-y.