Total Knee ArthroplastyNCT07006545
Return to Activity After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by University Hospital, Bonn at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Return to Activity Battery
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Apr 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage gonarthrosis, who have received a total knee arthroplasty
Who may be able to join
- Patients receiving a total knee arthroplasty
- Ability to perform the return to activity battery
Who cannot join
- Inability to perform the return to activity battery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Technical University Munich
Munich, Bavaria, 80333
About this study
Official title: Prospective, Multicenter Study of Clinical Rehabilitation and Return-to-activity After Total Knee Arthroplasty
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Return to Activity Battery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Patients receiving a total knee arthroplasty Receives: Other: Return to Activity Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Sonographically Analysis of the M. quadriceps femoris
Measured: Pre-OP to 12 months Post-OP
Muscle Strength
Isometric maximal strength of the knee extensors
Measured: Pre-OP to 12 Months Post-OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006545
- Sponsor's protocol ID
- 2024_I
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study of Clinical Rehabilitation and Return-to-activity After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07006545
- Acronym / sponsor ID
- 2024_I
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | – | Other: Return to Activity BatteryPatients receiving a total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage gonarthrosis, who have received a total knee arthroplasty
Key inclusion criteria (2 listed)
- Patients receiving a total knee arthroplasty
- Ability to perform the return to activity battery
Key exclusion criteria (1 listed)
- Inability to perform the return to activity battery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Return to Activity BatteryThe 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 | Other | Total Knee Arthroplasty |
Primary outcome
Muscle Mass
Time frame: Pre-OP to 12 months Post-OP
Sonographically Analysis of the M. quadriceps femoris
Muscle Strength
Time frame: Pre-OP to 12 Months Post-OP
Isometric maximal strength of the knee extensors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Mass (time frame: Pre-OP to 12 months Post-OP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.