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Recruiting NCT07183475

Return to Sports After Knee Arthroplasty

No phase Interventional Knee Osteoarthristis Arthroplasty Replacement, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Return to sports test.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis, Arthroplasty Replacement, Knee. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Diagnostic test Return 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

Primary outcome measures

  • Level of sports 1-4 [Time frame: Baseline at the time of measurement]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Germany · 1 center
  • Department of Orthopaedics and Sports Orthopaedics — Munich

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. PMID 27002707

Identifiers

NCT: NCT07183475 · 2023-687_1-S-CB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗