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Effects of Programmed Cryotherapy and Continuous Passive Motion After Computer-Assisted Total Knee Arthroplasty

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Patients With Osteoarthritis Undergoing CAS-TKA

Treatments

Other: Unrogramed cryotherapy and continuous passive motion
Other: Programed cryotherapy and continuous passive motion

Study type

Interventional

Funder types

Other

Identifiers

NCT04136431
201102015B0

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Intervention group
Experimental group
Treatment:
Other: Programed cryotherapy and continuous passive motion
Control group
Placebo Comparator group
Treatment:
Other: Unrogramed cryotherapy and continuous passive motion

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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