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Completed

NCT Number: NCT06381752

Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaetsmedizin der JGU Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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°

Treatment and study plan

Continuous Passive Motion

Device

Daily application of continuous passive motion

Standard Rehabilitation

Other

standard rehabilitation program with group physiotherapy

Primary outcomes

  1. Staffelstein Score

    Time frame: baseline (t0) and 3 weeks later (t1)

    A maximum score of 120 points is possible including 3 sub dimensions with a maximum score of 40 points each. Sub dimensions consist of pain, activities of daily life (ADL), and ROM. The Staffelstein Score is assessed by a professional investigator. Higher scores indicated better results.

Secondary outcomes

  1. Oxford Knee Score (OKS)

    Time frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3)

    Assessing patient's functional status. A maximum score of 48 points is possible including 12 questions with 0 - 4 points for each question [12]. Higher scores indicated better functional outcomes.

  2. Range of motion (ROM)

    Time frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline

    Range of motion (ROM): Assessing the patient's knee range of motion with a mechanical goniometer

  3. Visual Analogue Scale (VAS)

    Time frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2)

    The patient rates pain during rest and during movement and draws a vertical line on a 10cm line with 0 cm indicating no pain and 10 cm indicating maximum pain

  4. Return to work

    Time frame: baseline (t0), 4 months after baseline (t3)

    Assessed by post-operative days until first day of work

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement - A Prospective Randomized Controlled Multicenter Trial.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

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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