Osteo Arthritis KneeNCT05572359
Cryo and Compression Therapy After TKA and UKA
A study testing cryo-and compression brace in people with Osteo Arthritis Knee, run by Martini Hospital Groningen at 1 site in Netherlands.
Trial 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. 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?
- cryo-and compression brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2023to 16 Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients scheduled for a primary TKA or UKA in the Martini Hospital.
- Age ≥ 18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Martini ziekenhuis
Groningen, Provincie Groningen, 9728NT
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- cryo-and compression brace
- Keywords
- total knee arthroplasty, unicompartmental knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryo-and compression braceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty cryo-and compression group | Experimental | use of the cryo- and compression brace during the six postoperative weeks Receives: 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 Receives: Device: cryo-and compression brace |
| Unicompartmental knee arthroplasty regular care group | No intervention | regular care during the six postoperative weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain in rest
the NRS pain in rest will be assessed as an important measure of pain
Measured: 6 weeks postoperative
Secondary outcomes (16)
NRS pain in rest
the NRS pain in rest will be assessed as an important measure of pain
Measured: at baseline, daily during first 6 weeks after surgery and at 6 and 12 months
NRS pain during loading
the NRS pain during loading will be assessed as an additional measure of pain
Measured: at baseline, daily during first 6 weeks after surgery, 6 weeks postoperative, and at 6 and 12 months
opioid use
the amount of opioid use in case of excessive pain
Measured: daily during first 6 weeks after surgery
KOOS questionnaire (minus sport and recreation domain)
measure of symptoms of the knee
Measured: at baseline and 6 weeks after surgery
WORQ
measure of work ability (functioning)
Measured: at baseline and 6 weeks after surgery
active Range of Motion
measure of knee motion
Measured: at baseline and 6 weeks after surgery
knee circumference
measure of swelling of the knee
Measured: at baseline and 6 weeks after surgery
Timed Up and Go
measure of functional mobility
Measured: at baseline and 6 weeks after surgery
KOOS-PS
measure of symptoms of the knee
Measured: baseline, and 6 and 12 months after surgery
Oxford Knee score
measure of symptoms of the knee
Measured: baseline, and 6 and 12 months after surgery
EQ-5D 5L
measure of general health status
Measured: baseline, and 6 and 12 months after surgery
Frequency of the use of the cryo and compression brace
Compliance with cryo- and compression therapy
Measured: daily during first 6 weeks after surgery
NRS satisfaction
patient's satisfaction with the outcome after surgery
Measured: 6 weeks postoperative, 6 and 12 months 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)
Measured: 6 weeks postoperative, 6 and 12 months after surgery
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)
Measured: 6 weeks postoperative, 6 and 12 months after surgery
NRS patient satisfaction cryo and compression therapy
only for the intervention groups: satisfaction with the use and effectiveness of the intervention
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start25 May 2023
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- U-sport, Dutch Arthroplasty Register (LROI)
- Responsible party
- Sponsor
- Investigators
- Reinoud W. Brouwer, MD PhD, Principal investigator, Martini Hospital: Martini Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572359
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2022
- Last updated
- 27 Feb 2026
- 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
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.
PubMed 19729279Bourne 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.
PubMed 17891041Holm 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.
PubMed 21044725Levy 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.
PubMed 33027841Sadoghi 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.
PubMed 29356932Thijs 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 29725749Brouwers 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 33903923Ni 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.
PubMed 24928371Chughtai 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.
PubMed 28802778Schinsky 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.
PubMed 27648792Thienpont 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.
PubMed 25059851Soffin 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.
PubMed 27940457Martin 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.
PubMed 12072761Smith 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.
PubMed 11949239de 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.
PubMed 38286686
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryo- and Compression Therapy After Total Knee and Unicompartmental Arthroplasty, A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05572359
- Conditions
- Osteo Arthritis Knee
- Keywords
- total knee arthroplasty, unicompartmental knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Collaborators
- U-sport, Dutch Arthroplasty Register (LROI)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomly allocated to receive either cryo- and compression therapy during the first six weeks after surgery or standard care.
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty cryo-and compression group | Experimental | Device: cryo-and compression braceuse of the cryo- and compression brace during the six postoperative weeks |
| Total knee arthroplasty regular care group | No intervention | –regular care during the six postoperative weeks |
| Unicompartmental knee arthroplasty cryo- and compression group | Experimental | Device: cryo-and compression braceuse of the cryo- and compression brace during the six postoperative weeks |
| Unicompartmental knee arthroplasty regular care group | No intervention | –regular care during the six postoperative weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for a primary TKA or UKA in the Martini Hospital.
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryo-and compression bracepatients 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. | Device | Total knee arthroplasty cryo-and compression group, Unicompartmental knee arthroplasty cryo- and compression group |
Primary outcome
NRS pain in rest
Time frame: 6 weeks postoperative
the NRS pain in rest will be assessed as an important measure of pain
16 secondary outcomes
NRS pain in rest
Time frame: 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
opioid use
Time frame: daily during first 6 weeks after surgery
KOOS questionnaire (minus sport and recreation domain)
Time frame: at baseline and 6 weeks after surgery
WORQ
Time frame: at baseline and 6 weeks after surgery
active Range of Motion
Time frame: at baseline and 6 weeks after surgery
knee circumference
Time frame: at baseline and 6 weeks after surgery
Timed Up and Go
Time frame: at baseline and 6 weeks after surgery
KOOS-PS
Time frame: baseline, and 6 and 12 months after surgery
Oxford Knee score
Time frame: baseline, and 6 and 12 months after surgery
EQ-5D 5L
Time frame: 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
NRS satisfaction
Time frame: 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
achor question: patient perceived change in functioning
Time frame: 6 weeks postoperative, 6 and 12 months after surgery
NRS patient satisfaction cryo and compression therapy
Time frame: 6 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 19729279Adie 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.
- Background: PubMed 17891041Bourne 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.
- Background: PubMed 21044725Holm 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.
- Background: PubMed 33027841Levy 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.
- Background: PubMed 29356932Sadoghi 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.
- Background: PubMed 29725749Thijs 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.
- Background: PubMed 33903923Brouwers 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.
- Background: PubMed 24928371Ni 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.
- Background: PubMed 28802778Chughtai 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.
- Background: PubMed 27648792Schinsky 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.
- Background: PubMed 25059851Thienpont 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.
- Background: PubMed 27940457Soffin 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.
- Individual participant dataSharing planned: Yes. Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinoud W. Brouwer, MD PhD principal investigator
Martini Hospital: Martini Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryo-and compression brace in people with 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 6 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 27 Feb 2026. 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?
NRS pain in rest (time frame: 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 NCT05572359, which also lists 15 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 27 Feb 2026.