Total Hip Arthroplasty and Physical Activity in Patients Younger Than 50 Years (THA&PA)

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis; Physical Inactivity

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Erim Özdemir, Bsc; Phone Number: +31 6 43 808 376; Email: erim.ozdemir@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Recruiting
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be included from the patient population of the department of orthopaedics at the Radboudumc. Per year, approximately 80 patients under age of 50 years receive THA in this institute. The patient population has a male/female ratio of approximately 1:1.3, with multiple underlying diseases resulting in THA.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from time spent active in minutes per day	preoperative, 3 months postoperative, 12 months postoperative
Change from MVPA in minutes per day	preoperative, 3 months postoperative, 12 months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 8, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: THA&PA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No