Return to Sports After Knee Arthroplasty

NCT07183475 | Recruiting

• 1 other identifier: 2023-687_1-S-CB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthristis; Arthroplasty Replacement, Knee

Keywords

return to sports; knee oteoarthritis; knee arthroplasty

Outcome Measures

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.

  Baseline at the time of measurement

Study Arms (1)

RTS

EXPERIMENTAL

Return-to-sports-tested patients

Diagnostic Test: Return to sports test

Interventions

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.

RTS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Orthopaedics and Sports Orthopaedics

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Rüdiger von Eisenhart-Rothe, Univ. Prof. Dr. med.

  Department of Orthopaedics and Sports Orthopaedics

  STUDY CHAIR

Central Study Contacts

Christina Valle, Dr. med.

CONTACT

004915142483500; christina.valle@tum.de

Igor Lazic, PD Dr. med.

CONTACT

00498941406508; Igor.Lazic@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, prospective pilot study

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: July 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-08

Locations

DE (1)