Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

Knee Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037824
• Other study ID #: IFMK01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Institut de Formation en Masso-Kinésithérapie Saint Michel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cryotherapy Effect
• Joint Diseases
• Knee Arthropathy

Intervention

Other:
• cryotherapy
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.

Locations

Country	Name	City	State
France	Hôpital de la Porte Verte	Versailles	Yvelines

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Formation en Masso-Kinésithérapie Saint Michel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee range of motion	Measurement of passive flexion and active extension with a goniometer	Day 1-Day 8-Day 15-Day 21
Secondary	Knee perimetry	A perimetry measurement with a tape measure was carried out	Day 1-Day 8-Day 15-Day 21
Secondary	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.	Day 1-Day 8-Day 15-Day 21
Secondary	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.	Day 1-Day 8-Day 15-Day 21
Secondary	6min walking test	The instructions were to cover the greatest distance possible for 6 minutes	Day 1-Day 8-Day 15-Day 21
Secondary	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	Day 1-Day 8-Day 15-Day 21