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

NCT ID: NCT04136431

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-07
• Study Completion Date: 2013-03-05

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.

Conditions

Patients With Osteoarthritis Undergoing CAS-TKA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Programed cryotherapy and continuous passive motion

Intervention Type: OTHER

The intervention group started to use a CPM machine and applied programed cryotherapy intermittently within one hour while returning to the ward on the day of surgery.

Control group

Group Type: PLACEBO_COMPARATOR

Unrogramed cryotherapy and continuous passive motion

Intervention Type: OTHER

A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward

Interventions

Programed cryotherapy and continuous passive motion

The intervention group started to use a CPM machine and applied programed cryotherapy intermittently within one hour while returning to the ward on the day of surgery.

Intervention Type: OTHER

Unrogramed cryotherapy and continuous passive motion

A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 32883309 (View on PubMed)

Other Identifiers

201102015B0

Identifier Type: -

Identifier Source: org_study_id