Computer-assisted Cryotherapy After Total Knee Arthroplasty

NCT06730399 | Completed

• 1 other identifier: Cryotherapy in TKA patients
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis Knee

Keywords

cryotherapy; TKA; postoperative rehabilitation; pain; recovery; opioid

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) pain score in rest

  range 0-10, where a higher score indicates more pain

  assessed at 6 weeks postoperative

Secondary Outcomes (16)

• Numeric rating scale (NRS) pain score in rest

  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

  at baseline, daily during the first 7 days, after 2 and 6 weeks, and 6 and 12 months postoperative

• Opioid use

  daily during the first week after surgery

• active Range of Motion

  at baseline and at 6 weeks postoperative

• Timed Up and Go

  at baseline and at 6 weeks postoperative

Study Arms (2)

Cryotherapy group

Postoperative treatment using computed-assisted-cryotherapy in the first week postoperative in addition to usual care

Device: Computed-assisted-cryotherapy

Control group

Postoperative treatment according to usual care

Interventions

Computed-assisted-cryotherapy DEVICE

cryotherapy device

Cryotherapy group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• skin (or other) infections
• rheumatoid arthritis
• vascular disease
• having a strong preference for one of the two treatment options

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Hospital

Groningen, Provincie Groningen, Netherlands

Location

Related Publications (2)

• 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

• 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

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: August 1, 2019
• Primary Completion: June 9, 2020
• Study Completion: March 23, 2021
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)