Cryo and Compression Therapy After TKA and UKA

February 24, 2026 updated by: Martini Hospital Groningen

Effect of Cryo- and Compression Therapy After Total Knee and Unicompartmental Arthroplasty, A Randomised Controlled Trial

The goal of this clinical trial is to test the use of a cold and compression brace during the first 6 weeks after surgery in patients who had a total or partial knee replacement.

The main question[s] it aims to answer are:

  • What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain in rest?
  • What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain while loading, opioid use, functioning, patient satisfaction and general health, and do participants comply with the therapy?

Participants will be asked to use the cold and compression brace during the six weeks after surgery five times a day, for a maximum of 20 minutes. Researchers will compare with usual care to see the effect on pain, opioid use, functioning, satisfaction and general health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total and unicompartmental knee arthroplasty (TKA/UKA) is a widely accepted and effective treatment option for end-stage osteoarthritis (OA) of the knee. Significant long-term improvement in pain, function and quality of life after TKA are reported in literature, yet rehabilitation in the first three months remains challenging. Pain and swelling due to inflammatory reaction after tissue damage may obstruct effective rehabilitation in the early postoperative period. This could result in stiffness of the knee and patient dissatisfaction, also in the long-term. Despite encouraging results after implementing rapid recovery protocols with perioperative local infiltration analgesia and early mobilisation, treatment could still be optimised. Negative side effects (e.g., nausea, vomiting, dizziness) and the increasing abuse of opioid analgesics in modern society drives the search for alternative analgesic techniques. Cryotherapy could play a role in optimising rehabilitation after surgery. Cryotherapy involves the application of cold to the skin surrounding injured soft tissue. Application of cold reduces local blood flow due to vasoconstriction and ensuing the local inflammatory reaction, swelling and heat experience.

The effectiveness of cryotherapy on the recovery after surgery was studied in numerous studies and in the majority - but not in all - of these studies a beneficial effect of the cold therapy was found. Adie et al (2010) show in a systematic review and meta-analysis based on 11 RCT's that using cryotherapy the blood loss is significant lower and the range of motion is higher at discharge. In addition, a small effect on pain is found, cryotherapy leads to lower levels of pain at day 2. This effect was not found at day 1 and 3. No differences were found in complications, analgesics use, length of stay and swelling. Functioning was only measured in one study, so no conclusions could be drawn about that variable. These authors concluded that using cryotherapy postoperatively after a TKA might have benefits, but that the clinical relevance was uncertain. A more recent review performed by Ni et al (2015) confirmed, based on 12 studies, the beneficial results concerning blood loss and pain reduction on day 2. Also, no complications were documented related to the cryotherapy.

Sadoghi et al. (2018) focused on the effects of cryotherapy starting in the first postoperative week and found significant beneficial effects on pain on day 2 and knee flexion on day 6. They did not evidence significant effects in use of analgesics. By contrast, Thijs et al. (2019) found that patients in the cryotherapy group used 2.6 times less opioids as an escape medication during the first four postoperative days compared to the control group. Despite a significant reduction in NRS pain scores before and after cooling in the cryotherapy group, no clear differences on pain between the two groups in the first postoperative week were found. In the long-term too - 2, 6 and 12 weeks postoperatively - no differences could be evidenced. Our recently published RCT has shown that computer-assisted cryotherapy during the first postoperative week following TKA has beneficial in terms of pain reduction and diminished opioid consumption during this first week. At 6 weeks no differences in pain were found. Also the physical examination tests - aROM, knee circumference and Timed Up and Go - showed no difference between groups after 6 weeks. A period of only one week cooling postoperatively can be a reason for short term beneficial effect of the cryotherapy. To our knowledge, no study has been conducted on the effects of 6 weeks cryo and compression therapy after a TKA and UKA.

There are several ways to apply cryotherapy, using ice or cold packs, or mechanical devices which create a standardized cooling treatment of the injured tissue, with and without compression. A review of the currently available literature in TKA and UKA patients stated that standardized continuous cold flow with compression was associated with better outcomes. However, since the financial aspect is also a major element in patient care, cost-effectiveness must be considered as well. Cost benefit analyses demonstrated that simpler devices as ice bag compression bandages or cold packs are far less costly, with no disadvantage in outcomes in several studies. This makes that in the current study an easy-to-use brace with an inserted cold pack, that can be applied with a close fit to the knee, with optional application of manual compression will be used. The combination of cold and compression was suggested to result in longer and improved anaesthetic effect after application.

Primary objective:

Investigating the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after surgery (TKA en UKA) on pain in rest.

Secondary objective:

Investigating the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after TKA/UKA surgery on pain while loading, opioid use, functioning, self-perceived change in pain, patient satisfaction and general health. Also the compliance with the cold- and compression therapy will be investigated.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9728NT
        • Martini Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for a primary TKA or UKA in the Martini Hospital.
  • Age ≥ 18 years

Exclusion Criteria:

  • per-operative switch from UKA to TKA (only applicable for the UKA patients),
  • revision TKA implant (only applicable for the TKA patients),
  • rheumatoid arthritis,
  • other co-morbidities on which cooling may have a negative effect on (based on judgement of the orthopaedic surgeon),
  • inability to read and understand the Dutch language.

Because the cool pack needs to be cooled in a freezer, it is required that a patient or the nursing home has a freezer that can be used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total knee arthroplasty cryo-and compression group
use of the cryo- and compression brace during the six postoperative weeks
Device: cryo-and compression brace
patients in the intervention groups are instructed to use the cryo- and compression brace during the six postoperative weeks five times a day, for a maximum of 20 minutes. The amount of compression is dependent on a patients' own preference.
No Intervention: Total knee arthroplasty regular care group
regular care during the six postoperative weeks
Experimental: Unicompartmental knee arthroplasty cryo- and compression group
use of the cryo- and compression brace during the six postoperative weeks
Device: cryo-and compression brace
patients in the intervention groups are instructed to use the cryo- and compression brace during the six postoperative weeks five times a day, for a maximum of 20 minutes. The amount of compression is dependent on a patients' own preference.
No Intervention: Unicompartmental knee arthroplasty regular care group
regular care during the six postoperative weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS pain in rest
Time Frame: 6 weeks postoperative
the NRS pain in rest will be assessed as an important measure of pain
6 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS pain in rest
Time Frame: at baseline, daily during first 6 weeks after surgery and at 6 and 12 months
the NRS pain in rest will be assessed as an important measure of pain
at baseline, daily during first 6 weeks after surgery and at 6 and 12 months
NRS pain during loading
Time Frame: at baseline, daily during first 6 weeks after surgery, 6 weeks postoperative, and at 6 and 12 months
the NRS pain during loading will be assessed as an additional measure of pain
at baseline, daily during first 6 weeks after surgery, 6 weeks postoperative, and at 6 and 12 months
opioid use
Time Frame: daily during first 6 weeks after surgery
the amount of opioid use in case of excessive pain
daily during first 6 weeks after surgery
KOOS questionnaire (minus sport and recreation domain)
Time Frame: at baseline and 6 weeks after surgery
measure of symptoms of the knee
at baseline and 6 weeks after surgery
WORQ
Time Frame: at baseline and 6 weeks after surgery
measure of work ability (functioning)
at baseline and 6 weeks after surgery
active Range of Motion
Time Frame: at baseline and 6 weeks after surgery
measure of knee motion
at baseline and 6 weeks after surgery
knee circumference
Time Frame: at baseline and 6 weeks after surgery
measure of swelling of the knee
at baseline and 6 weeks after surgery
Timed Up and Go
Time Frame: at baseline and 6 weeks after surgery
measure of functional mobility
at baseline and 6 weeks after surgery
KOOS-PS
Time Frame: baseline, and 6 and 12 months after surgery
measure of symptoms of the knee
baseline, and 6 and 12 months after surgery
Oxford Knee score
Time Frame: baseline, and 6 and 12 months after surgery
measure of symptoms of the knee
baseline, and 6 and 12 months after surgery
EQ-5D 5L
Time Frame: baseline, and 6 and 12 months after surgery
measure of general health status
baseline, and 6 and 12 months after surgery
Frequency of the use of the cryo and compression brace
Time Frame: daily during first 6 weeks after surgery
Compliance with cryo- and compression therapy
daily during first 6 weeks after surgery
NRS satisfaction
Time Frame: 6 weeks postoperative, 6 and 12 months after surgery
patient's satisfaction with the outcome after surgery
6 weeks postoperative, 6 and 12 months after surgery
achor question: patient perceived change in pain
Time Frame: 6 weeks postoperative, 6 and 12 months after surgery
the degree in which a patient experiences an improvement in pain compared to baseline (7 point Likert scale)
6 weeks postoperative, 6 and 12 months after surgery
achor question: patient perceived change in functioning
Time Frame: 6 weeks postoperative, 6 and 12 months after surgery
the degree in which a patient experiences an improvement in functioning compared to baseline (7 point Likert scale)
6 weeks postoperative, 6 and 12 months after surgery
NRS patient satisfaction cryo and compression therapy
Time Frame: 6 weeks postoperative
only for the intervention groups: satisfaction with the use and effectiveness of the intervention
6 weeks postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications using the cold compression brace
Time Frame: The first 6 postoperative weeks
Documentation of complications related to the use of the cold compression brace, including the risk of frostbite and other inconveniences.
The first 6 postoperative weeks
Complications using the cold compression brace
Time Frame: Time frame: during the first postoperative year
Documentation of complications after surgery (infections, re-operations)
Time frame: during the first postoperative year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martini Hospital Groningen

Collaborators

U-sport
Dutch Arthroplasty Register (LROI)

Investigators

  • Principal Investigator: Reinoud W. Brouwer, MD PhD, Martini Hospital: Martini Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Actual)

February 16, 2026

Study Completion (Actual)

February 16, 2026

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on cryo-and compression brace

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe