Clinical trial NCT06838455: Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Official title: Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Hip
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Spinopelvic radiographic measurements
timeFrame: Change from baseline to up to 1 hour after spinopelvic exercises same day.
measure: Lumbar mobility
timeFrame: Change from baseline to up to 1 hour after spinopelvic exercises same day
measure: Spinopelvic mobility
timeFrame: Change from baseline to up to 1 hour after spinopelvic exercises same day
measure: Patient risk classification for THA instability
timeFrame: Change from baseline to up to 1 hour after spinopelvic exercises same day
Secondary outcomes:
measure: Oswestry Disability Index score
timeFrame: Baseline
measure: Hip Society Score
timeFrame: Baseline
measure: Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
timeFrame: Baseline
measure: The Veterans Rand 12-Item Health Survey scores (VR-12)
timeFrame: Baseline
measure: Use of medication for hip/back pain
timeFrame: Baseline
measure: Severity of hip arthritis
timeFrame: Baseline
measure: Adverse events
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Colorado Joint Replacement
name: Dennis Douglas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.