NCT06381752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 5, 2024

Last Update Submit

April 19, 2024

Conditions

Total Knee Arthroplasty

Keywords

CPMinpatient rehabilitationStaffelstein Score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Oxford Knee Score (OKS)

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

  • Range of motion (ROM)

    baseline (t0), 10 days after baseline (t1), 3 weeks after baseline

  • Visual Analogue Scale (VAS)

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

  • Return to work

    baseline (t0), 4 months after baseline (t3)

Study Arms (2)

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

OTHER

Invervention group

Device: Continuous passive motion

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

OTHER

Control group

Other: standard rehabilitation

Interventions

Continuous passive motionDEVICE

Daily application of continuous passive motion

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

standard rehabilitation program with group physiotherapy

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaetsmedizin der JGU Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Interventions

Motion Therapy, Continuous Passive

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMusculoskeletal Manipulations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 24, 2024

Study Start

June 25, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)