Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

NCT ID: NCT06381752

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2020-03-31

Brief Summary

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Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes.

Detailed Description

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The aim of this study is to analyze the value (knee function, pain, and quality of life) of continuous passive motion (CPM) after total knee replacement (TKR), when it partially replaces group physiotherapy (PT) in inpatient rehabilitation to save human resources. Patients are randomized to CPM group, consisting of 3 daily sessions of 20 minutes each, or to group PT, consisting of 25 minutes physiotherapy in groups 5 days weekly. Multimodal rehabilitation does not differ for both groups throughout the 3-week rehabilitation stay.

Primary outcome is the Staffelstein Score, German standard score in rehabilitation. Secondary outcomes are Oxford Knee Score (OKS), active and passive range of motion (ROM), and pain on visual analogue scale (VAS). Return to work is assessed by post-operative days.

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: CPM the

Invervention group

Group Type OTHER

Continuous passive motion

Intervention Type DEVICE

Daily application of continuous passive motion

Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: group p

Control group

Group Type OTHER

standard rehabilitation

Intervention Type OTHER

standard rehabilitation program with group physiotherapy

Interventions

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Continuous passive motion

Daily application of continuous passive motion

Intervention Type DEVICE

standard rehabilitation

standard rehabilitation program with group physiotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Total knee arthroplasty because of knee osteoarthritis
* Inpatient rehabilitation in participating clinics

Exclusion Criteria

* Pregnancy
* Not able to give informed consent
* Psychological disorders
* Body weight \> 150 kg
* Hip range of motion \< 50°
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Erol Gercek

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitaetsmedizin der JGU Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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CPMvsPT

Identifier Type: -

Identifier Source: org_study_id

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