Cryo and Compression Therapy After TKA and UKA

NCT05572359 | Completed

• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

total knee arthroplasty; unicompartmental knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• NRS pain in rest

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

  6 weeks postoperative

Secondary Outcomes (16)

• NRS pain in rest

  at baseline, daily during first 6 weeks after surgery and at 6 and 12 months

• NRS pain during loading

  at baseline, daily during first 6 weeks after surgery, 6 weeks postoperative, and at 6 and 12 months

• opioid use

  daily during first 6 weeks after surgery

• KOOS questionnaire (minus sport and recreation domain)

  at baseline and 6 weeks after surgery

• WORQ

  at baseline and 6 weeks after surgery

Other Outcomes (2)

• Complications using the cold compression brace

  The first 6 postoperative weeks

• Complications using the cold compression brace

  Time frame: during the first postoperative year

Study Arms (4)

Total knee arthroplasty cryo-and compression group

EXPERIMENTAL

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

Device: cryo-and compression brace

Total knee arthroplasty regular care group

NO INTERVENTION

regular care during the six postoperative weeks

Unicompartmental knee arthroplasty cryo- and compression group

EXPERIMENTAL

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

Device: cryo-and compression brace

Unicompartmental knee arthroplasty regular care group

NO INTERVENTION

regular care during the six postoperative weeks

Interventions

cryo-and compression brace DEVICE

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.

Total knee arthroplasty cryo-and compression group; Unicompartmental knee arthroplasty cryo- and compression group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• U-sport: collaborator
• Martini Hospital Groningen: lead
• Dutch Arthroplasty Register (LROI): collaborator

Study Sites (1)

Martini ziekenhuis

Groningen, Provincie Groningen, 9728NT, Netherlands

Location

Related Publications (15)

• 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.

  PMID: 19729279 BACKGROUND

• 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.

  PMID: 17891041 BACKGROUND

• 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.

  PMID: 21044725 BACKGROUND

• 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.

  PMID: 33027841 BACKGROUND

• 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.

  PMID: 29356932 BACKGROUND

• 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.

  PMID: 29725749 BACKGROUND

• 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.

  PMID: 33903923 BACKGROUND

• 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.

  PMID: 24928371 BACKGROUND

• 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.

  PMID: 28802778 BACKGROUND

• 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.

  PMID: 27648792 BACKGROUND

• 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.

  PMID: 25059851 BACKGROUND

• 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.

  PMID: 27940457 BACKGROUND

• 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.

  PMID: 12072761 BACKGROUND

• 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.

  PMID: 11949239 BACKGROUND

• de Vries AJ, Aksakal HK, Brouwer RW. Effects of 6 weeks of cryotherapy plus compression therapy after total or unicompartmental knee arthroplasty: protocol for a single-centre, single-blind randomised controlled trial. BMJ Open. 2024 Jan 29;14(1):e077614. doi: 10.1136/bmjopen-2023-077614.

  PMID: 38286686 DERIVED

Study Officials

• Reinoud W. Brouwer, MD PhD

  Martini Hospital: Martini Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly allocated to receive either cryo- and compression therapy during the first six weeks after surgery or standard care.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: May 25, 2023
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)