Outpatient remobilization after total knee and hip arthroplasties

Phase 4

• Conditions: M16.1; M17.1; Other primary coxarthrosis; Other primary gonarthrosis

• Registration Number: DRKS00028152
• Lead Sponsor: udwig Boltzmann Gesellschaft, Ludwig Boltzmann Institute for Rehabilitation Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Study Completion: 2023-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Planned unilateral knee or hip replacement for gonarthrosis.
• Relatively painless and symptom-free contralateral lower extremity (no effusion, no load-limiting pain, VAS less than 5)
• Age between 55 and 80 years
• Good general health with good exercise capacity (defined by exclusion criteria)
• Inclusion of men and non-childbearing women (postmenopausal and other reasons, to be confirmed by pregnancy test in case of doubt)

Exclusion Criteria

• Previous knee or hip arthroplasty
• Body mass index (BMI) greater than 40
• Any conditions/states according to fresh leg vein thrombosis (shorter than 3 weeks),
• Higher degree of joint effusion
• infection
• Pre-existing myopathy
• Relevant neurological diseases with gait disturbance (Polyneuropathies, MB, Parkinson's)
• Dementia / reduced cognitive abilities
• Vestibular diseases with vertigo or balance disorders
• Symptomatic cardiopulmonary disease in the past 6 months
• Arterial hypertension not or insufficiently controlled by medication
• Peripheral arterial occlusive disease (pAVK)
• Malignant diseases
• Rheumatic diseases and other internal contraindications
• Other relevant functional impairment of the musculoskeletal system due to previous surgery, injury and degenerative diseases

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timed up and go test (TUGT) at five measurement time points. 2 weeks before surgery and 2, 6, 10 and 26 weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
2 weeks before surgery and 2, 6, 10, and 26 weeks after surgery:<br>• Pain in the joint at rest and on exertion (VAS).<br>• Body composition (BIA)<br>• Circumferential measurement of the lower extremity<br>• Isokinetic force measurement in dynamometer<br>• Stair climbing test<br>• 10m walk test<br>• Range of motion (ROM) of the affected and unaffected joint<br>• Questionnaire EQ5, HAQ, SAF, WOMAC<br>• Blood samples<br>• Saliva samples<br><br>Optional on volunteers 2 weeks before surgery and 10 weeks after surgery:<br>• Muscle biopsy M. quadriceps