NCT06037824

Brief Summary

In the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is unanimously recommended, including the use of cryotherapy. However, there is no consensus regarding the methods of application of cryotherapy. Thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

3.2 years

First QC Date

August 31, 2023

Last Update Submit

September 7, 2023

Conditions

Knee ArthropathyCryotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • knee range of motion

    Measurement of passive flexion and active extension with a goniometer

    Day 1-Day 8-Day 15-Day 21

Secondary Outcomes (5)

  • Knee perimetry

    Day 1-Day 8-Day 15-Day 21

  • Swelling

    Day 1-Day 8-Day 15-Day 21

  • Pain at rest and on exertion

    Day 1-Day 8-Day 15-Day 21

  • 6min walking test

    Day 1-Day 8-Day 15-Day 21

  • KOOS score (Knee injury and Osteoarthritis Outcome Score)

    Day 1-Day 8-Day 15-Day 21

Study Arms (2)

Experimental Group

EXPERIMENTAL

This group received classic rehabilitation\* + compressive cryotherapy \* classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.

Other: cryotherapy

Control Group

ACTIVE COMPARATOR

This group received classic rehabilitation\* + classic cryotherapy \*classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.

Other: cryotherapy

Interventions

cryotherapyOTHER

cryotherapy was added to rehabilitation\*. One group received compressive cryotherapy and the other conventional cold pack cryotherapy. \* rehabilitation includes (="classic rehabilitation") passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.

Control GroupExperimental Group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers
  • First-line Total Knee Arthroplasty on an indication of knee osteoarthritis diagnosed by radio-clinical examination
  • Between D3 and D10 postoperatively
  • Age \< 90 years.

You may not qualify if:

  • Intolerance to cryotherapy or compression,
  • Occurrence of complications secondary to surgery,
  • Withdrawal of consent,
  • Non-compliance with the rehabilitation protocol (content and dosage of sessions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Porte Verte

Versailles, Yvelines, 78000, France

Location

Related Publications (1)

  • Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7.

    PMID: 38419032DERIVED

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 14, 2023

Study Start

January 1, 2019

Primary Completion

March 22, 2022

Study Completion

June 30, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

FR(1)