Return to Sports After Knee Arthroplasty

NCT ID: NCT07183475

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-07-31

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.

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.

Conditions

Knee Osteoarthristis; Arthroplasty Replacement, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

RTS

Return-to-sports-tested patients

Group Type: EXPERIMENTAL

Return to sports test

Intervention Type: 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.

Interventions

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 and prevents injury during the testing process.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_CHAIR

Department of Orthopaedics and Sports Orthopaedics

Locations

Department of Orthopaedics and Sports Orthopaedics

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christina Valle, Dr. med.

Role: CONTACT

christina.valle@tum.de

004915142483500

Igor Lazic, PD Dr. med.

Role: CONTACT

Igor.Lazic@mri.tum.de

00498941406508

Facility Contacts

Christina Valle, Dr. med.

Role: primary

christina.valle@tum.de

00491514248600

Igor Lazic, PD Dr. med.

Role: backup

Igor.Lazic@mri.tum.de

00498941406508

References

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.

Reference Type: BACKGROUND

PMID: 27002707 (View on PubMed)

Other Identifiers

2023-687_1-S-CB

Identifier Type: -

Identifier Source: org_study_id