search
Back to results

Cryo and Compression Therapy After TKA and UKA

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cryo-and compression brace
Sponsored by
Martini Hospital Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteo Arthritis Knee focused on measuring total knee arthroplasty, unicompartmental knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Martini ziekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Total knee arthroplasty cryo-and compression group

Total knee arthroplasty regular care group

Unicompartmental knee arthroplasty cryo- and compression group

Unicompartmental knee arthroplasty regular care group

Arm Description

use of the cryo- and compression brace during the six postoperative weeks

regular care during the six postoperative weeks

use of the cryo- and compression brace during the six postoperative weeks

regular care during the six postoperative weeks

Outcomes

Primary Outcome Measures

NRS pain in rest
the NRS pain in rest will be assessed as an important measure of pain

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2022
Last Updated
July 4, 2023
Sponsor
Martini Hospital Groningen
Collaborators
U-sport, Dutch Arthroplasty Register (LROI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05572359
Brief Title
Cryo and Compression Therapy After TKA and UKA
Official Title
Effect of Cryo- and Compression Therapy After Total Knee and Unicompartmental Arthroplasty, A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Martini Hospital Groningen
Collaborators
U-sport, Dutch Arthroplasty Register (LROI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
total knee arthroplasty, unicompartmental knee arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated to receive either cryo- and compression therapy during the first six weeks after surgery or standard care.
Masking
Outcomes Assessor
Masking Description
During the baseline visit the preoperative questionnaires will be obtained from the patient and the physical examination tests will be performed. Only after this is finished, at the end of this visit, the randomisation will be performed by opening a sealed envelope. All patients will be invited for a study control visit after 6 weeks. During the appointment a blinded assessor (not one of the researchers involved in the baseline measurements) will first perform the physical examination tests, after which a check of the completeness of the questionnaires will be done. Finally, the log will be checked. Patients are instructed not to talk about the intervention they received until the log was checked. In this way the preceding measurements can be performed blinded.
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total knee arthroplasty cryo-and compression group
Arm Type
Experimental
Arm Description
use of the cryo- and compression brace during the six postoperative weeks
Arm Title
Total knee arthroplasty regular care group
Arm Type
No Intervention
Arm Description
regular care during the six postoperative weeks
Arm Title
Unicompartmental knee arthroplasty cryo- and compression group
Arm Type
Experimental
Arm Description
use of the cryo- and compression brace during the six postoperative weeks
Arm Title
Unicompartmental knee arthroplasty regular care group
Arm Type
No Intervention
Arm Description
regular care during the six postoperative weeks
Intervention Type
Device
Intervention Name(s)
cryo-and compression brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
NRS pain in rest
Description
the NRS pain in rest will be assessed as an important measure of pain
Time Frame
6 weeks postoperative
Secondary Outcome Measure Information:
Title
NRS pain in rest
Description
the NRS pain in rest will be assessed as an important measure of pain
Time Frame
at baseline, daily during first 6 weeks after surgery and at 6 and 12 months
Title
NRS pain during loading
Description
the NRS pain during loading will be assessed as an additional measure of pain
Time Frame
at baseline, daily during first 6 weeks after surgery, 6 weeks postoperative, and at 6 and 12 months
Title
opioid use
Description
the amount of opioid use in case of excessive pain
Time Frame
daily during first 6 weeks after surgery
Title
KOOS questionnaire (minus sport and recreation domain)
Description
measure of symptoms of the knee
Time Frame
at baseline and 6 weeks after surgery
Title
WORQ
Description
measure of work ability (functioning)
Time Frame
at baseline and 6 weeks after surgery
Title
active Range of Motion
Description
measure of knee motion
Time Frame
at baseline and 6 weeks after surgery
Title
knee circumference
Description
measure of swelling of the knee
Time Frame
at baseline and 6 weeks after surgery
Title
Timed Up and Go
Description
measure of functional mobility
Time Frame
at baseline and 6 weeks after surgery
Title
KOOS-PS
Description
measure of symptoms of the knee
Time Frame
baseline, and 6 and 12 months after surgery
Title
Oxford Knee score
Description
measure of symptoms of the knee
Time Frame
baseline, and 6 and 12 months after surgery
Title
EQ-5D 5L
Description
measure of general health status
Time Frame
baseline, and 6 and 12 months after surgery
Title
Frequency of the use of the cryo and compression brace
Description
Compliance with cryo- and compression therapy
Time Frame
daily during first 6 weeks after surgery
Title
NRS satisfaction
Description
patient's satisfaction with the outcome after surgery
Time Frame
6 weeks postoperative, 6 and 12 months after surgery
Title
achor question: patient perceived change in pain
Description
the degree in which a patient experiences an improvement in pain compared to baseline (7 point Likert scale)
Time Frame
6 weeks postoperative, 6 and 12 months after surgery
Title
achor question: patient perceived change in functioning
Description
the degree in which a patient experiences an improvement in functioning compared to baseline (7 point Likert scale)
Time Frame
6 weeks postoperative, 6 and 12 months after surgery
Title
NRS patient satisfaction cryo and compression therapy
Description
only for the intervention groups: satisfaction with the use and effectiveness of the intervention
Time Frame
6 weeks postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid J. de Vries, PhD
Phone
050 524 5960
Email
a.devries3@mzh.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Reinoud W. Brouwer, MD PhD
Phone
050 524 5970
Email
r.w.brouwer@mzh.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinoud W. Brouwer, MD PhD
Organizational Affiliation
Martini Hospital: Martini Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martini ziekenhuis
City
Groningen
ZIP/Postal Code
9728NT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid De vries
Phone
0505245960
Email
A.deVries3@mzh.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.
Citations:
PubMed Identifier
19729279
Citation
Adie S, Naylor JM, Harris IA. Cryotherapy after total knee arthroplasty a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2010 Aug;25(5):709-15. doi: 10.1016/j.arth.2009.07.010. Epub 2009 Sep 2.
Results Reference
background
PubMed Identifier
17891041
Citation
Bourne RB, McCalden RW, MacDonald SJ, Mokete L, Guerin J. Influence of patient factors on TKA outcomes at 5 to 11 years followup. Clin Orthop Relat Res. 2007 Nov;464:27-31. doi: 10.1097/BLO.0b013e318159c5ff.
Results Reference
background
PubMed Identifier
21044725
Citation
Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
Results Reference
background
PubMed Identifier
33027841
Citation
Levy N, Quinlan J, El-Boghdadly K, Fawcett WJ, Agarwal V, Bastable RB, Cox FJ, de Boer HD, Dowdy SC, Hattingh K, Knaggs RD, Mariano ER, Pelosi P, Scott MJ, Lobo DN, Macintyre PE. An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients. Anaesthesia. 2021 Apr;76(4):520-536. doi: 10.1111/anae.15262. Epub 2020 Oct 7.
Results Reference
background
PubMed Identifier
29356932
Citation
Sadoghi P, Hasenhutl S, Gruber G, Leitner L, Leithner A, Rumpold-Seitlinger G, Kastner N, Poolman RW, Glehr M. Impact of a new cryotherapy device on early rehabilitation after primary total knee arthroplasty (TKA): a prospective randomised controlled trial. Int Orthop. 2018 Jun;42(6):1265-1273. doi: 10.1007/s00264-018-3766-5. Epub 2018 Jan 22.
Results Reference
background
PubMed Identifier
29725749
Citation
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.
Results Reference
background
PubMed Identifier
33903923
Citation
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.
Results Reference
background
PubMed Identifier
24928371
Citation
Ni SH, Jiang WT, Guo L, Jin YH, Jiang TL, Zhao Y, Zhao J. Cryotherapy on postoperative rehabilitation of joint arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3354-61. doi: 10.1007/s00167-014-3135-x. Epub 2014 Jun 14.
Results Reference
background
PubMed Identifier
28802778
Citation
Chughtai M, Sodhi N, Jawad M, Newman JM, Khlopas A, Bhave A, Mont MA. Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. J Arthroplasty. 2017 Dec;32(12):3822-3832. doi: 10.1016/j.arth.2017.07.016. Epub 2017 Jul 21.
Results Reference
background
PubMed Identifier
27648792
Citation
Schinsky MF, McCune C, Bonomi J. Multifaceted Comparison of Two Cryotherapy Devices Used After Total Knee Arthroplasty: Cryotherapy Device Comparison. Orthop Nurs. 2016 Sep-Oct;35(5):309-16. doi: 10.1097/NOR.0000000000000276.
Results Reference
background
PubMed Identifier
25059851
Citation
Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. 2014 Nov;472(11):3417-23. doi: 10.1007/s11999-014-3810-8. Epub 2014 Jul 25.
Results Reference
background
PubMed Identifier
27940457
Citation
Soffin EM, YaDeau JT. Enhanced recovery after surgery for primary hip and knee arthroplasty: a review of the evidence. Br J Anaesth. 2016 Dec;117(suppl 3):iii62-iii72. doi: 10.1093/bja/aew362.
Results Reference
background
PubMed Identifier
12072761
Citation
Martin SS, Spindler KP, Tarter JW, Detwiler KB. Does cryotherapy affect intraarticular temperature after knee arthroscopy? Clin Orthop Relat Res. 2002 Jul;(400):184-9. doi: 10.1097/00003086-200207000-00023.
Results Reference
background
PubMed Identifier
11949239
Citation
Smith J, Stevens J, Taylor M, Tibbey J. A randomized, controlled trial comparing compression bandaging and cold therapy in postoperative total knee replacement surgery. Orthop Nurs. 2002 Mar-Apr;21(2):61-6. doi: 10.1097/00006416-200203000-00009.
Results Reference
background

Learn more about this trial

Cryo and Compression Therapy After TKA and UKA

We'll reach out to this number within 24 hrs