Effectiveness of Therapeutic Exercises on Spinopelvic Mobility

NCT06838455 | Not Yet Recruiting

• 1 other identifier: 2279537
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis (OA) of the Hip

Outcome Measures

Primary Outcomes (4)

• Spinopelvic radiographic measurements

  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.

  Change from baseline to up to 1 hour after spinopelvic exercises same day.

• Lumbar mobility

  Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs.

  Change from baseline to up to 1 hour after spinopelvic exercises same day

• Spinopelvic mobility

  Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs.

  Change from baseline to up to 1 hour after spinopelvic exercises same day

• Patient risk classification for THA instability

  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)

  Change from baseline to up to 1 hour after spinopelvic exercises same day

Secondary Outcomes (7)

• Oswestry Disability Index score

  Baseline

• Hip Society Score

  Baseline

• Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)

  Baseline

• The Veterans Rand 12-Item Health Survey scores (VR-12)

  Baseline

• Use of medication for hip/back pain

  Baseline

Study Arms (1)

Spinopelvic Exercise

EXPERIMENTAL

Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video.

Other: Spinopelvic mobility exercise

Interventions

Spinopelvic mobility exercise OTHER

Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. The exercise regimen has been developed by the investigators of this study to incorporate exercises to increase a patient's spinopelvic mobility. Study staff that has been properly trained will be present to guide the patient through the exercise regimen and ensure the exercises are being performed accurately.

Spinopelvic Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients undergoing revision total hip arthroplasty.
• Patients with spinal fusion.
• Patients who exercised prior to radiographic analysis.
• Patients unable to complete imaging at the designated time of day.
• Symptomatic contralateral hip osteoarthritis.
• 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.

Sponsors & Collaborators

• Colorado Joint Replacement: lead

Related Publications (10)

• Dagneaux L, Marouby S, Maillot C, Canovas F, Riviere C. Dual mobility device reduces the risk of prosthetic hip instability for patients with degenerated spine: A case-control study. Orthop Traumatol Surg Res. 2019 May;105(3):461-466. doi: 10.1016/j.otsr.2018.12.003. Epub 2018 Dec 26.

  PMID: 30594599 BACKGROUND

• Haws BE, Khechen B, Patel DV, Louie PK, Iyer S, Cardinal KL, Guntin JA, Singh K. Sagittal Imbalance Does Not Influence Cup Anteversion in Total Hip Arthroplasty Dislocations. Clin Spine Surg. 2019 Feb;32(1):E31-E36. doi: 10.1097/BSD.0000000000000712.

  PMID: 30247184 BACKGROUND

• Buckland AJ, Abotsi EJ, Vasquez-Montes D, Ayres EW, Varlotta CG, Vigdorchik JM. Lumbar Spine Degeneration and Flatback Deformity Alter Sitting-Standing Spinopelvic Mechanics-Implications for Total Hip Arthroplasty. J Arthroplasty. 2020 Apr;35(4):1036-1041. doi: 10.1016/j.arth.2019.11.020. Epub 2019 Nov 22.

  PMID: 31839349 BACKGROUND

• Buckland AJ, Fernandez L, Shimmin AJ, Bare JV, McMahon SJ, Vigdorchik JM. Effects of Sagittal Spinal Alignment on Postural Pelvic Mobility in Total Hip Arthroplasty Candidates. J Arthroplasty. 2019 Nov;34(11):2663-2668. doi: 10.1016/j.arth.2019.06.036. Epub 2019 Jun 22.

  PMID: 31301908 BACKGROUND

• Lum ZC, Coury JG, Cohen JL, Dorr LD. The Current Knowledge on Spinopelvic Mobility. J Arthroplasty. 2018 Jan;33(1):291-296. doi: 10.1016/j.arth.2017.08.013. Epub 2017 Aug 24.

  PMID: 28939031 BACKGROUND

• Murphy WS, Yun HH, Hayden B, Kowal JH, Murphy SB. The Safe Zone Range for Cup Anteversion Is Narrower Than for Inclination in THA. Clin Orthop Relat Res. 2018 Feb;476(2):325-335. doi: 10.1007/s11999.0000000000000051.

  PMID: 29529664 BACKGROUND

• Abdel MP, von Roth P, Jennings MT, Hanssen AD, Pagnano MW. What Safe Zone? The Vast Majority of Dislocated THAs Are Within the Lewinnek Safe Zone for Acetabular Component Position. Clin Orthop Relat Res. 2016 Feb;474(2):386-91. doi: 10.1007/s11999-015-4432-5.

  PMID: 26150264 BACKGROUND

• Esposito CI, Carroll KM, Sculco PK, Padgett DE, Jerabek SA, Mayman DJ. Total Hip Arthroplasty Patients With Fixed Spinopelvic Alignment Are at Higher Risk of Hip Dislocation. J Arthroplasty. 2018 May;33(5):1449-1454. doi: 10.1016/j.arth.2017.12.005. Epub 2017 Dec 13.

  PMID: 29310920 BACKGROUND

• Tezuka T, Heckmann ND, Bodner RJ, Dorr LD. Functional Safe Zone Is Superior to the Lewinnek Safe Zone for Total Hip Arthroplasty: Why the Lewinnek Safe Zone Is Not Always Predictive of Stability. J Arthroplasty. 2019 Jan;34(1):3-8. doi: 10.1016/j.arth.2018.10.034. Epub 2018 Nov 2.

  PMID: 30454867 BACKGROUND

• Ike H, Dorr LD, Trasolini N, Stefl M, McKnight B, Heckmann N. Spine-Pelvis-Hip Relationship in the Functioning of a Total Hip Replacement. J Bone Joint Surg Am. 2018 Sep 19;100(18):1606-1615. doi: 10.2106/JBJS.17.00403. No abstract available.

  PMID: 30234627 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dennis Douglas, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makenna Hemmerle, MS

CONTACT

3032602951; makenna.hemmerle@adventhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share