Effectiveness of Therapeutic Exercises on Spinopelvic Mobility

Not Applicable

Not yet recruiting

• Conditions: Osteoarthritis (OA) of the Hip

• Registration Number: NCT06838455
• Lead Sponsor: Colorado Joint Replacement

Brief Summary

The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Patients aged 18-90 scheduled for total hip arthroplasty
2. Patients with primary hip osteoarthritis
3. Patients with or without history of prior spinal injections

Exclusion Criteria

1. Patients undergoing revision total hip arthroplasty.
2. Patients with spinal fusion.
3. Patients who exercised prior to radiographic analysis.
4. Patients unable to complete imaging at the designated time of day.
5. Symptomatic contralateral hip osteoarthritis.
6. Patients unwilling or unable to perform therapeutic exercise program as instructed. This includes patients requiring use of assistive devices or who would be deemed unsafe to perform the exercises without a 1- or 2-person assist.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Spinopelvic radiographic measurements	Change from baseline to up to 1 hour after spinopelvic exercises same day.	Spinopelvic parameter measurements on pre- and post-exercise radiographs including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. All measurements are angles calculated in degrees.
Lumbar mobility	Change from baseline to up to 1 hour after spinopelvic exercises same day	Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs.
Spinopelvic mobility	Change from baseline to up to 1 hour after spinopelvic exercises same day	Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs.
Patient risk classification for THA instability	Change from baseline to up to 1 hour after spinopelvic exercises same day	Risk classification based on previously published risk factors for THA instability (lumbar stiffness, abnormal pelvic mobility, standing pelvic tilt greater than 13, sagittal spinal deformity)

Secondary Outcome Measures

Name	Time	Method
Adverse events	Day 1	Any adverse events sustained from therapeutic exercises
Oswestry Disability Index score	Baseline	Patient reported outcome for pre-existing back pain and disability. The questionnaire is comprised of 10 sections, where each section is scored on a scale from 0 to 5 and summed. Higher score totals indicates worse disability.
Hip Society Score	Baseline	Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.
Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)	Baseline	Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.
The Veterans Rand 12-Item Health Survey scores (VR-12)	Baseline	Patient reported outcome. Scores are reported as a Z-score that is based on the United States population average of 50. Higher scores indicate better outcomes.
Use of medication for hip/back pain	Baseline	Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement.
Severity of hip arthritis	Baseline	Graded using Kellgren-Lawrence scale for osteoarthritis on AP radiographs. Grades are between 0-4, where 0 indicates an absence of osteoarthritis and a 4 indicates severe osteoarthritis.