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Completed

NCT Number: NCT06037824

Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Arthropathy Cryotherapy Effect

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Porte Verte

Versailles, Yvelines, 78000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cryotherapy

Other

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 outcomes

  1. knee range of motion

    Time frame: Day 1-Day 8-Day 15-Day 21

    Measurement of passive flexion and active extension with a goniometer

Secondary outcomes

  1. Knee perimetry

    Time frame: Day 1-Day 8-Day 15-Day 21

    A perimetry measurement with a tape measure was carried out

  2. Swelling

    Time frame: Day 1-Day 8-Day 15-Day 21

    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.

  3. Pain at rest and on exertion

    Time frame: Day 1-Day 8-Day 15-Day 21

    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.

  4. 6min walking test

    Time frame: Day 1-Day 8-Day 15-Day 21

    The instructions were to cover the greatest distance possible for 6 minutes

  5. KOOS score (Knee injury and Osteoarthritis Outcome Score)

    Time frame: Day 1-Day 8-Day 15-Day 21

    Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions

Sponsors and collaborators

Lead sponsor

Institut de Formation en Masso-Kinésithérapie Saint Michel

Other

Registry information

Official study title

Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 14, 2023
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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