Computer-assisted Cryotherapy After Total Knee Arthroplasty

The Role of Computer-assisted Cryotherapy in the Postoperative Treatment After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Computed-assisted-cryotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Martini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is recruited from one large peripheral hospital in the Netherlands, the Martini Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryotherapy group; Postoperative treatment using computed-assisted-cryotherapy in the first week postoperative in addition to usual care	Device: Computed-assisted-cryotherapy; cryotherapy device
Control group; Postoperative treatment according to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS) pain score in rest	range 0-10, where a higher score indicates more pain	assessed at 6 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	The amount of opioid use in case of excessive pain	daily during the first week after surgery
Complications/Serious adverse events	Keep record of the complications that occurred	from baseline until 12 months postoperative
Numeric rating scale (NRS) pain score in rest	range 0-10, where a higher score indicates more pain	at baseline, daily during the first 7 days, after 2 weeks, and 6 and 12 months postoperative
Numeric rating scale (NRS) pain scores while loading	range 0-10, where a higher score indicates more pain	at baseline, daily during the first 7 days, after 2 and 6 weeks, and 6 and 12 months postoperative
active Range of Motion	in degrees	at baseline and at 6 weeks postoperative
Timed Up and Go	In seconds. Measure of functional mobility.	at baseline and at 6 weeks postoperative
Knee circumference	in centimeters	at baseline and at 6 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Without the sports and recreation domain. Range 0-100, where a higher score indicates less symptoms.	preoperative and 2 and 6 weeks postoperative
Work, Osteoarthritis en joint-Replacement Questionnaire (WORQ)	Measure of work ability (functioning). Range 0-100, where a higher score indicates less functional limitations.	preoperative and 2 and 6 weeks postoperative
EuroQol 5D (EQ5D) - 5 point Likert scale	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).	preoperative and 6 and 12 months postoperative
Oxford knee scores	Range 0-48, where a higher score indicates less symptoms.	preoperative and 6 and 12 months postoperative
KOOS-PS scores (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)	Range 0-100, where a higher score indicates less symptoms	preoperative, and 6 and 12 months postoperative
Numeric rating scale (NRS) satisfaction	patient's satisfaction with the outcome after surgery at that time point, range 0-10, where a higher score indicates more satisfaction	2 and 6 weeks postoperative, and 6 and 12 months postoperative
anchor question: patient perceived change in pain	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)	6 and 12 months postoperative
anchor question: patient perceived change in functioning	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)	6 and 12 months postoperative
Numeric rating scal (NRS) satisfaction cryotherapy	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.	1 week postoperative

Collaborators and Investigators

• Sponsor: Martini Hospital Groningen

Publications and helpful links

General Publications

• Thijs E, Schotanus MGM, Bemelmans YFL, Kort NP. Reduced opiate use after total knee arthroplasty using computer-assisted cryotherapy. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1204-1212. doi: 10.1007/s00167-018-4962-y. Epub 2018 May 3.
• Brouwers HFG, de Vries AJ, van Zuilen M, van Kouswijk HW, Brouwer RW. The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2698-2706. doi: 10.1007/s00167-021-06568-x. Epub 2021 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): March 23, 2021

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: opioid; pain; cryotherapy; recovery; TKA; postoperative rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Cryotherapy in TKA patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No