Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

NCT07366736 | Recruiting

• 1 other identifier: 2025-A01217-42
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion. Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term. The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.

Conditions

Compression; Total Knee Anthroplasty; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• To compare post-operative pain between the intervention and the control group

  Pain measured on numeric rating scale (NRS) at 48 hours postoperatively. 0 means no pain and 10 means severe pain.

  48 hours postoperatively

Secondary Outcomes (9)

• To compare post-operative pain during the study

  1, 3, and 9 months

• To compare the evolution of joint function

  preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months

• To compare the evolution of mobility

  preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 months

• To compare the incidence of oedema

  preoperatively, and postoperatively at 48 hours and at 1, 3, and 9 month

• To compare wound healing

  preoperatively, postoperatively at 48 hours and at 1, and 3 months

Study Arms (2)

Icepacks

ACTIVE COMPARATOR

Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery.

Device: Cryotherapy

Cryocompression

EXPERIMENTAL

Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery.

Device: Game Ready

Interventions

Cryotherapy DEVICE

Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the icepacks to reduce inflammation. The patients will use icepacks for 4 hours consecutively directly following surgery.

Icepacks

Game Ready DEVICE

Directly following the surgery, the patient will go to the 'wake-up' area and will stay in the hospital for the next 1 to 3 days, during which the patients will use the cryocompression to reduce inflammation. The patients will use cryocompression for 4 hours consecutively directly following surgery.

Cryocompression

Eligibility Criteria

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

You may qualify if:

• aged ≥18 years
• scheduled for primary TKR
• BMI \<40 kg/m2
• who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
• affiliated with a social security scheme
• with an ability to answer questionnaires and to communicate freely in French.

You may not qualify if:

• underwent revision TKR
• underwent bilateral TKR
• who cannot comply with the protocol requirements based on the investigator's judgment
• that are pregnant or breastfeeding
• with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code

Sponsors & Collaborators

• Clinique des Cèdres: lead

Study Sites (1)

Clinique des Cèdres

Échirolles, 38130, France

RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: January 26, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): July 27, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)