Knee OsteoarthristisRTSNCT07183475
Return to Sports After Knee Arthroplasty
A study testing Return to sports test in people with Knee Osteoarthristis and Arthroplasty Replacement, Knee, run by Technical University of Munich at 1 site in Germany.
Trial summary
The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthristis, Arthroplasty Replacement, Knee
- What is being tested?
- Return to sports test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2025to 31 Jul 2027
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study includes all patients with a history of unicondylar or bicondylar knee joint replacement and engagement in sports activity.
- All participating patients have provided their informed consent following comprehensive information and explanation.
- All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving detailed information and clarification.
Who cannot join
- Patients who are unable to understand the patient information and study design (e.g., due to language barriers) or whose compliance is deemed insufficient by the study team
- No knee joint endoprosthesis implanted
- No engagement in athletic activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Sports Orthopaedics
Munich, Bavaria, 81675
Christina Valle, Dr. med., 00491514248600, christina.valle@tum.de
Igor Lazic, PD Dr. med., 00498941406508, Igor.Lazic@mri.tum.de
About this study
Official title: Amendment to the Study "Prospective, Multicenter Investigation of Clinical Rehabilitation and Everyday Recovery Following Knee Joint Endoprosthetic Replacement" With Additional Return-to-sports-testing at One Participating Center
The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic performance and prevent re-injury. These tests allow a stepwise evaluation of a subject's physical readiness for sports.
In the field of arthroplasty, and despite increasing sports activity among patients with joint arthroplasty such structured assessment is still lacking. As a result, patients with arthroplasty typically resume sports activities based solely on individual recommendations from the surgeon or treating therapist. However, an objective evaluation of sports capability is currently not available.
Therefore the amendment intends to expand the current testing protocol of the already registered and ongoing study (Protocol ID: UBonn_TKA_FollowUp) to include additional standardized, evidence-based return-to-sprort-tests.
Read the detailed description
These return-to-sports-tests are based on validated procedures commonly used in sports orthopaedics, particularly following the stepwise testing concept described by Keller et al..
Initially, the participant's individual sport level is determined via structured anamnesis. This is then followed by level-specific functional testing. Participants who do not perform Level 1 testing correctly will not proceed to Level 2 testing -even if their anamnesis suggests a higher sport level. This stepwise approach ensures safety and prevents injury during the testing process.
- Being tested
- Return to sports test
- Keywords
- return to sports, knee oteoarthritis, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return to sports testDiagnostic test
The return-to-sport-tests are based on validated procedures commonly used in sports orthopedics, particularly following the stepwise testing concept described.
Initially, the participant's individual sport level is determined via structured anamnesis. This is then followed by level-specific functional testing. Participants who do not perform Level 1 testing correctly will not proceed to Level 2 testing-even if their anamnesis suggests a higher sport level. This stepwise approach ensures safety and prevents injury during the testing process.
| Study group | Role | What they receive |
|---|---|---|
| RTS | Experimental | Return-to-sports-tested patients Receives: Diagnostic Test: Return to sports test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of sports 1-4
Levels of sports are divided into four levels:
- Sports without jumping;
- Dynamic sports without pivoting or abrupt stopping movements;
- Sports involving lateral movements and moderate pivoting or stopping motions (less intense than in Level 4);
- Sports with jumping, rapid pivoting, and sudden stopping movements.
Measured: Baseline at the time of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, prospective pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rüdiger von Eisenhart-Rothe, Univ. Prof. Dr. med., Study chair, Department of Orthopaedics and Sports Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183475
- Sponsor's protocol ID
- 2023-687_1-S-CB
- Acronym
- RTS
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The assessment regarding IPD with our data protection officer in relation to German and European data protection law has not yet been completed.
Publications
Keller M, Kurz E, Schmidtlein O, Welsch G, Anders C. [Interdisciplinary Assessment Criteria for Rehabilitation after Injuries of the Lower Extremity: A Function-Based Return to Activity Algorithm]. Sportverletz Sportschaden. 2016 Mar;30(1):38-49. doi: 10.1055/s-0042-100966. Epub 2016 Mar 22. German.
PubMed 27002707
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amendment to the Study "Prospective, Multicenter Investigation of Clinical Rehabilitation and Everyday Recovery Following Knee Joint Endoprosthetic Replacement" With Additional Return-to-sports-testing at One Participating Center
- ClinicalTrials.gov ID
- NCT07183475
- Acronym / sponsor ID
- RTS / 2023-687_1-S-CB
- Keywords
- return to sports, knee oteoarthritis, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 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.
The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic performance and prevent re-injury. These tests allow a stepwise evaluation of a subject's physical readiness for sports.
In the field of arthroplasty, and despite increasing sports activity among patients with joint arthroplasty such structured assessment is still lacking. As a result, patients with arthroplasty typically resume sports activities based solely on individual recommendations from the surgeon or treating therapist. However, an objective evaluation of sports capability is currently not available.
Therefore the amendment intends to expand the current testing protocol of the already registered and ongoing study (Protocol ID: UBonn_TKA_FollowUp) to include additional standardized, evidence-based return-to-sprort-tests.
Detailed description
These return-to-sports-tests are based on validated procedures commonly used in sports orthopaedics, particularly following the stepwise testing concept described by Keller et al..
Initially, the participant's individual sport level is determined via structured anamnesis. This is then followed by level-specific functional testing. Participants who do not perform Level 1 testing correctly will not proceed to Level 2 testing -even if their anamnesis suggests a higher sport level. This stepwise approach ensures safety and prevents injury during the testing process.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| RTS | Experimental | Diagnostic Test: Return to sports testReturn-to-sports-tested patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study includes all patients with a history of unicondylar or bicondylar knee joint replacement and engagement in sports activity.
- All participating patients have provided their informed consent following comprehensive information and explanation.
- All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving detailed information and clarification.
Key exclusion criteria (3 listed)
- Patients who are unable to understand the patient information and study design (e.g., due to language barriers) or whose compliance is deemed insufficient by the study team
- No knee joint endoprosthesis implanted
- No engagement in athletic activity
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 sports testThe return-to-sport-tests are based on validated procedures commonly used in sports orthopedics, particularly following the stepwise testing concept described. Initially, the participant's individual sport level is determined via structured anamnesis. This is then followed by level-specific functional testing. Participants who do not perform Level 1 testing correctly will not proceed to Level 2 testing-even if their anamnesis suggests a higher sport level. This stepwise approach ensures safety and prevents injury during the testing process. | Diagnostic test | RTS |
Primary outcome
Level of sports 1-4
Time frame: Baseline at the time of measurement
Levels of sports are divided into four levels: 1. Sports without jumping; 2. Dynamic sports without pivoting or abrupt stopping movements; 3. Sports involving lateral movements and moderate pivoting or stopping motions (less intense than in Level 4); 4. Sports with jumping, rapid pivoting, and sudden stopping movements.
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 19 Sep 2025.
- Background: PubMed 27002707Keller M, Kurz E, Schmidtlein O, Welsch G, Anders C. [Interdisciplinary Assessment Criteria for Rehabilitation after Injuries of the Lower Extremity: A Function-Based Return to Activity Algorithm]. Sportverletz Sportschaden. 2016 Mar;30(1):38-49. doi: 10.1055/s-0042-100966. Epub 2016 Mar 22. German.
- Individual participant dataSharing planned: Undecided. The assessment regarding IPD with our data protection officer in relation to German and European data protection law has not yet been completed.
Related trials for Knee Osteoarthristis
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Study NRPT Feasibility in Knee Osteoarthritis
Knee Osteoarthristis
Not yet recruitingEarly Phase 1
Medication vs. Meditation for Chronic Knee Osteoarthritis
Knee Osteoarthristis
Not yet recruiting
Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list
Knee Osteoarthristis
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
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.
Rüdiger von Eisenhart-Rothe, Univ. Prof. Dr. med. study chair
Department of Orthopaedics and Sports Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return to sports test in people with Knee Osteoarthristis and Arthroplasty Replacement, Knee, run by Technical University of Munich at 1 site 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Christina Valle, Dr. med. (004915142483500, christina.valle@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of sports 1-4 (time frame: Baseline at the time of measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183475, which also lists 1 linked publication.
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 19 Sep 2025.