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NCT Number: NCT07183475

Return to Sports After Knee Arthroplasty

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.

Recruiting

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Key information

Conditions

Knee Osteoarthristis Arthroplasty Replacement, Knee

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Return to sports test

Diagnostic 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.

Primary outcomes

  1. Level of sports 1-4

    Time frame: Baseline at the time of measurement

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Valle, Dr. med.

CONTACT

[email protected]

004915142483500

Igor Lazic, PD Dr. med.

CONTACT

[email protected]

00498941406508

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study 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

Acronym: RTS

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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