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Osteo Arthritis KneeNCT06730399

Computer-Assisted Cryotherapy After Total Knee Arthroplasty

An observational study of Osteo Arthritis Knee, run by Martini Hospital Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Computed-assisted-cryotherapy
Type of treatment
Medical device
How many people
106 participants
Where
1 siteNetherlands
Study dates
1 Aug 2019to 23 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Martini Hospital

    Groningen, Provincie Groningen

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Computed-assisted-cryotherapy
Keywords
cryotherapy, TKA, postoperative rehabilitation, pain, recovery, opioid
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed-assisted-cryotherapyDevice

    cryotherapy device

Study groups in NCT06730399
Study groupRoleWhat they receive
Cryotherapy groupPostoperative treatment using computed-assisted-cryotherapy in the first week postoperative in addition to usual care
Receives: Device: Computed-assisted-cryotherapy
Control groupPostoperative treatment according to usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric rating scale (NRS) pain score in rest

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

    Measured: assessed at 6 weeks postoperative

Secondary outcomes (16)

  1. Numeric rating scale (NRS) pain score in rest

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

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

  2. Numeric rating scale (NRS) pain scores while loading

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

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

  3. Opioid use

    The amount of opioid use in case of excessive pain

    Measured: daily during the first week after surgery

  4. active Range of Motion

    in degrees

    Measured: at baseline and at 6 weeks postoperative

  5. Timed Up and Go

    In seconds. Measure of functional mobility.

    Measured: at baseline and at 6 weeks postoperative

  6. Knee circumference

    in centimeters

    Measured: at baseline and at 6 weeks postoperative

  7. Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

    Without the sports and recreation domain. Range 0-100, where a higher score indicates less symptoms.

    Measured: preoperative and 2 and 6 weeks postoperative

  8. Work, Osteoarthritis en joint-Replacement Questionnaire (WORQ)

    Measure of work ability (functioning). Range 0-100, where a higher score indicates less functional limitations.

    Measured: preoperative and 2 and 6 weeks postoperative

  9. 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).

    Measured: preoperative and 6 and 12 months postoperative

  10. Oxford knee scores

    Range 0-48, where a higher score indicates less symptoms.

    Measured: preoperative and 6 and 12 months postoperative

  11. KOOS-PS scores (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)

    Range 0-100, where a higher score indicates less symptoms

    Measured: preoperative, and 6 and 12 months postoperative

  12. 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

    Measured: 2 and 6 weeks postoperative, and 6 and 12 months postoperative

  13. 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)

    Measured: 6 and 12 months postoperative

  14. 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)

    Measured: 6 and 12 months postoperative

  15. 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.

    Measured: 1 week postoperative

  16. Complications/Serious adverse events

    Keep record of the complications that occurred

    Measured: from baseline until 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start1 Aug 2019
  3. Primary completion9 Jun 2020
  4. Study completion23 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730399
Sponsor's protocol ID
Cryotherapy in TKA patients
Status last verified
Jan 2025
First submitted
9 Dec 2024
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.

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.

    PubMed 29725749

  • 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.

    PubMed 33903923

Questions about this trial

What is this clinical trial studying?

An observational study of Osteo Arthritis Knee, run by Martini Hospital Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric rating scale (NRS) pain score in rest (time frame: assessed at 6 weeks postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730399, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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