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Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

Primary Purpose

Knee Arthropathy, Cryotherapy Effect

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
Institut de Formation en Masso-Kinésithérapie Saint Michel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • Hôpital de la Porte Verte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

knee range of motion
Measurement of passive flexion and active extension with a goniometer

Secondary Outcome Measures

Knee perimetry
A perimetry measurement with a tape measure was carried out
Swelling
Swelling has been measured with the "fluctuation test": the examiner placed his thumb and fingers on either side of the lower part of the patella, while with his other hand, he positioned himself at the level of the upper part of the sub quadriceps fornix. The fingers of the cranial hand exerted light pressure to mobilize the fluid from the quadriceps fornix. The test was positive if the fingers or thumb were pushed back by the effusion.
Pain at rest and on exertion
Pain assessment was based on the use of the Verbal Numerical Scale (NVS). The examiner asked the subject to quantify their pain on a scale ranging from 0 to 10 (0 corresponding to no pain and 10 to unbearable pain). Pain assessment was carried out at rest and during exercise during the rehabilitation sessions.
6min walking test
The instructions were to cover the greatest distance possible for 6 minutes
KOOS score (Knee injury and Osteoarthritis Outcome Score)
Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions

Full Information

First Posted
August 31, 2023
Last Updated
September 7, 2023
Sponsor
Institut de Formation en Masso-Kinésithérapie Saint Michel
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1. Study Identification

Unique Protocol Identification Number
NCT06037824
Brief Title
Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty
Official Title
Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Formation en Masso-Kinésithérapie Saint Michel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Cryotherapy Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
knee range of motion
Description
Measurement of passive flexion and active extension with a goniometer
Time Frame
Day 1-Day 8-Day 15-Day 21
Secondary Outcome Measure Information:
Title
Knee perimetry
Description
A perimetry measurement with a tape measure was carried out
Time Frame
Day 1-Day 8-Day 15-Day 21
Title
Swelling
Description
Swelling has been measured with the "fluctuation test": the examiner placed his thumb and fingers on either side of the lower part of the patella, while with his other hand, he positioned himself at the level of the upper part of the sub quadriceps fornix. The fingers of the cranial hand exerted light pressure to mobilize the fluid from the quadriceps fornix. The test was positive if the fingers or thumb were pushed back by the effusion.
Time Frame
Day 1-Day 8-Day 15-Day 21
Title
Pain at rest and on exertion
Description
Pain assessment was based on the use of the Verbal Numerical Scale (NVS). The examiner asked the subject to quantify their pain on a scale ranging from 0 to 10 (0 corresponding to no pain and 10 to unbearable pain). Pain assessment was carried out at rest and during exercise during the rehabilitation sessions.
Time Frame
Day 1-Day 8-Day 15-Day 21
Title
6min walking test
Description
The instructions were to cover the greatest distance possible for 6 minutes
Time Frame
Day 1-Day 8-Day 15-Day 21
Title
KOOS score (Knee injury and Osteoarthritis Outcome Score)
Description
Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions
Time Frame
Day 1-Day 8-Day 15-Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
Hôpital de la Porte Verte
City
Versailles
State/Province
Yvelines
ZIP/Postal Code
78000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

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