NCT07006545

Brief Summary

This multicenter research project aims to correlate objective testing of muscle mass, muscle strength, neuromuscular activation, walking speed and other functional tests with everyday activity and subjective quality of life after total knee arthroplasty. For this purpose, 400 patients from 5 orthopedic departments in Germany and USA will be examined at the time points pre-op, six weeks, three, six and 12 months post-op.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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 Progress70%
Apr 2024Jul 2027

Study Start

First participant enrolled

April 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

May 28, 2025

Last Update Submit

May 28, 2025

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Muscle Mass

    Sonographically Analysis of the M. quadriceps femoris

    Pre-OP to 12 months Post-OP

  • Muscle Strength

    Isometric maximal strength of the knee extensors

    Pre-OP to 12 Months Post-OP

Study Arms (1)

Total Knee Arthroplasty

Patients receiving a total knee arthroplasty

Other: Return to Activity Battery

Interventions

Return to Activity BatteryOTHER

The main target parameters are muscle mass (sonography), muscle strength (isometric maximum strength measurement), neuromuscular activation (surface EMG), functionality (e.g. 6MWT, chair rising test), knee swelling and subjective assessment of everyday and leisure activities, quality of life (e.g. SF-36) and return to work

Total Knee Arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end-stage gonarthrosis, who have received a total knee arthroplasty

You may qualify if:

  • Patients receiving a total knee arthroplasty
  • Ability to perform the return to activity battery

You may not qualify if:

  • Inability to perform the return to activity battery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Technical University Munich

Munich, Bavaria, 80333, Germany

Location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., B.Sc.

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)