Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Other: standard rehabilitation; Device: Continuous passive motion

• Registration Number: NCT06381752
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-25
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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°

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: group p	standard rehabilitation	Control group
Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: CPM the	Continuous passive motion	Invervention group

Primary Outcome Measures

Name	Time	Method
Staffelstein Score	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 Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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
Return to work	baseline (t0), 4 months after baseline (t3)	Assessed by post-operative days until first day of work
Oxford Knee Score (OKS)	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.
Range of motion (ROM)	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

Trial Locations

Locations (1)

Universitaetsmedizin der JGU Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany