CClinicalTrials.gg
RecruitingNCT07183475RTSUpdated Sep 19, 2025

Return to Sports After Knee Arthroplasty

An interventional study of Return to sports test in Knee Osteoarthristis and Arthroplasty Replacement, Knee, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Technical University of Munich · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Knee Osteoarthristis
  • Arthroplasty Replacement, Knee

Keywords

  • return to sports
  • knee oteoarthritis
  • knee arthroplasty
03

In context

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    RTS

    Return-to-sports-tested patients

    Diagnostic Test: Return to sports test

Interventions

  • Diagnostic testReturn to sports 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.

06

What researchers measure

Primary outcomes

  1. Level of sports 1-4

    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.

    Time frame: Baseline at the time of measurement

07

Study locations

1 of 1 sites recruiting
  • Department of Orthopaedics and Sports Orthopaedics
    Munich, Bavaria 81675, Germany
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — The assessment regarding IPD with our data protection officer in relation to German and European data protection law has not yet been completed.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07183475
Lead sponsor
Technical University of Munich
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Jul 15, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 19, 2025

Study contacts

Christina Valle, Dr. med.
Contact
christina.valle@tum.de
004915142483500
Igor Lazic, PD Dr. med.
Contact
Igor.Lazic@mri.tum.de
00498941406508
Rüdiger von Eisenhart-Rothe, Univ. Prof. Dr. med.
study chair · Department of Orthopaedics and Sports Orthopaedics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion