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Clinical Trials/NCT05189964
NCT05189964
Recruiting
Not Applicable

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

Radboud University Medical Center1 site in 1 country90 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Radboud University Medical Center
Enrollment
90
Locations
1
Primary Endpoint
Change from MVPA in minutes per day
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
October 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change from MVPA in minutes per day

Time Frame: preoperative, 3 months postoperative, 12 months postoperative

Change from time spent active in minutes per day

Time Frame: preoperative, 3 months postoperative, 12 months postoperative

Secondary Outcomes

  • 6MWT(preoperative, 3 months postoperative, 12 months postoperative)
  • COPM(preoperative, 12 months postoperative)
  • TUG(preoperative, 3 months postoperative, 12 months postoperative)

Study Sites (1)

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