Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06381752
• Other study ID #: CPMvsPT
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2024
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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°

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Continuous passive motion
Daily application of continuous passive motion

Other:
• standard rehabilitation
standard rehabilitation program with group physiotherapy

Locations

Country	Name	City	State
Germany	Universitaetsmedizin der JGU Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staffelstein Score	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.	baseline (t0) and 3 weeks later (t1)
Secondary	Oxford Knee Score (OKS)	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.	baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3)
Secondary	Range of motion (ROM)	Range of motion (ROM): Assessing the patient's knee range of motion with a mechanical goniometer	baseline (t0), 10 days after baseline (t1), 3 weeks after baseline
Secondary	Visual Analogue Scale (VAS)	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	baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2)
Secondary	Return to work	Assessed by post-operative days until first day of work	baseline (t0), 4 months after baseline (t3)