Total Hip Arthroplasty and Physical Activity in Patients Younger Than 50 Years

Recruiting

• Conditions: Hip Osteoarthritis; Physical Inactivity

• Registration Number: NCT05189964
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. However, these young patients and their doctors don't know which increase in physical activity can be expected.

Objective: To measure the difference in physical activity before and after THA. Study design: Longitudinal prospective single center observational study. Study population: 87 patients who have primary THA under the age of 50 years. Excluding patients with an underlying oncologic disease which results in THA.

Intervention: N.a. Main study parameters/endpoints: The first primary endpoint is physical activity in minutes per day. The other primary endpoint is MVPA in minutes per day. Secondary endpoints are difference of TUG outcomes in seconds and the difference of 6MWT outcomes in meters. For the patients experience, the COPM total scores and NRS pain scores will be measured.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study requires three outpatient clinic visits. These visits will coincide with regular outpatient clinic visits, so patients will not have to come in extra for this study. During the preoperative and 1 year postoperative visit, the patients will complete the COPM. The patient will wear a PA monitor for 7 days after each visit. Patients might experience confronting feelings while being exposed to their PA activity profile after the study or experience mild discomfort while wearing the PA monitor since it will be worn 24 hours per day for 7 days. Also, filling in the questionnaires will take some time (5-10 minutes per questionnaire series). There are no significant physical risks associated to this study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-08
• Last Update Submitted: 2022-01-08
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2023-12-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• The age of the patient is between 16 and 50 years.
• The patient has an indication for primary THA.

Exclusion Criteria

• Patients with an underlying oncologic disease which results in THA.
• Patients who are not able to walk.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from MVPA in minutes per day	preoperative, 3 months postoperative, 12 months postoperative
Change from time spent active in minutes per day	preoperative, 3 months postoperative, 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
6MWT	preoperative, 3 months postoperative, 12 months postoperative	6 minute walking test
COPM	preoperative, 12 months postoperative	Canadian Occupational Performance Measure total scores
TUG	preoperative, 3 months postoperative, 12 months postoperative	Timed Up \& Go

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands