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TerminatedNCT05059535CryogenouUpdated May 16, 2025

Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

A Phase 4 interventional study of standard pain relievers in Knee Injuries, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Phase 4, Interventional, and Prevention

Why this study was terminated
the recruitment rate is far too low despite an 18-month extension of the inclusion period
Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.

02

Conditions studied

  • Knee Injuries

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03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's enrollment of 52 is close to the median of 50 across 160 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years and ≤ 80 years;
  • Patient to undergo prosthetic knee surgery;
  • Patient in good health (ASA score 1 to 3);
  • Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion criteria

Exclusion Criteria:

  • Known intolerance to any of the products administered during surgery or cryoneurolysis;
  • Patient with an electric implant;
  • Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);
  • Drug addict patient;
  • Intervention on septic bone;
  • Chronic renal failure (creatinine clearance \<30 mL / min);
  • History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;
  • Pregnant or breastfeeding woman;
  • Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
  • Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
  • Patient not beneficiary of a social security scheme.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    cryoneurolysis of the saphenous nerve

    A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty

    Drug: standard pain relievers

  • Experimental
    cryoneurolysis of geniculate nerves

    A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty

    Drug: standard pain relievers

  • Placebo comparator
    control

    No cryoneurolysis will be performed before the knee arthroplasty

    Drug: standard pain relievers

Interventions

  • Drugstandard pain relievers

    Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice

    Also known as: Standard pain relievers in accordance with the current practice

06

What researchers measure

Primary outcomes

  1. 90 ° flexion pain 2 days after the arthroscopy

    Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

    Time frame: 2 days

Secondary outcomes

  1. 90 ° flexion pain 1 day after the arthroscopy

    Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

    Time frame: 1 day

  2. 90 ° flexion pain 7 days after the arthroscopy

    Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

    Time frame: 7 days

  3. 90 ° flexion pain 30 days after the arthroscopy

    Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

    Time frame: 30 days

  4. 90 ° flexion pain 90 days after the arthroscopy

    Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm

    Time frame: 90 days

  5. pain at rest at Day 1

    Knee pain after intervention with a visual analogic scale of 100 mm

    Time frame: 1 day

  6. pain at rest at Day 2

    Knee pain after intervention with a visual analogic scale of 100 mm

    Time frame: 2 days

  7. pain at rest at Day 7

    Knee pain after intervention with a visual analogic scale of 100 mm

    Time frame: 7 days

  8. pain at rest at Day 30

    Knee pain after intervention with a visual analogic scale of 100 mm

    Time frame: 30 days

  9. pain at rest at Day 90

    Knee pain after intervention with a visual analogic scale of 100 mm

    Time frame: 90 days

07

Study locations

1 site
  • Hôpital privé Paul d'Egine
    Champigny-sur-marne, 94500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05059535
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
Euraxi Pharma
Responsible party
Sponsor
First posted
Sep 28, 2021
Start date
Jan 12, 2022
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025
Last update
May 16, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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