NCT06944808

Brief Summary

This study investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 18, 2025

Last Update Submit

April 18, 2025

Conditions

Osteoarthritis Knees

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain

    Visual Analog Scale (0-100mm)

    Pre- to 6 week Post-OP

  • Muscle Mass

    Sonographic measure of the diameter of the M. vastus mediales and lateralis

    Pre- to 6 week Post-OP

Study Arms (2)

Sham-BFR + Electrical Stimulation

ACTIVE COMPARATOR

Patients received a daily postoperative passive therapy with a sham-BFR intervention (20mmHg) and electrical stimulation of the M. vastus laterals and mediales.

Other: Sham-BFR + EMS

BFR + Electrical Stimulation

EXPERIMENTAL

Patients received a daily postoperative passive therapy with a BFR intervention (80% of the individual LOP) and electrical stimulation of the M. vastus laterals and mediales.

Other: BFR + EMS

Interventions

Sham-BFR + EMSOTHER

Daily passive sham-BFR with a fixed pressure of 20mmHg in combination with electrical stimulation of the m. vastus lateralis and mediales

Sham-BFR + Electrical Stimulation
BFR + EMSOTHER

Daily passive BFR with an individual pressure of 80% of the limb occlusion pressure in combination with electrical stimulation of the m. vastus lateralis and mediales

BFR + Electrical Stimulation

Eligibility Criteria

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

You may qualify if:

  • Indication for elective total knee arthroplasty
  • Understanding of the study and ability for informed consent

You may not qualify if:

  • Open wounds of the lower extremities
  • Stents or bypasses on the location of pressure application
  • Sickle Cell Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., B.Sc.

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 25, 2025

Study Start

September 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)