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Not yet recruitingNCT06838455Updated Feb 20, 2025

Effectiveness of Therapeutic Exercises on Spinopelvic Mobility

An interventional study of Spinopelvic mobility exercise in Osteoarthritis (OA) of the Hip, sponsored by Colorado Joint Replacement. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Colorado Joint Replacement · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis (OA) of the Hip

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 53 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Colorado Joint Replacement is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    Spinopelvic Exercise

    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

  • OtherSpinopelvic mobility exercise

    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.

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What researchers measure

Primary outcomes

  1. 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.

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

  2. Lumbar mobility

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

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

  3. Spinopelvic mobility

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

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

  4. 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)

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

Secondary outcomes

  1. Oswestry Disability Index score

    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.

    Time frame: Baseline

  2. Hip Society Score

    Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.

    Time frame: Baseline

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

    Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.

    Time frame: Baseline

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

    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.

    Time frame: Baseline

  5. Use of medication for hip/back pain

    Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement.

    Time frame: Baseline

  6. Severity of hip arthritis

    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.

    Time frame: Baseline

  7. Adverse events

    Any adverse events sustained from therapeutic exercises

    Time frame: Day 1

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30594599 ↗
  • 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. PubMed 30247184 ↗
  • 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. PubMed 31839349 ↗
  • 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. PubMed 31301908 ↗
  • 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. PubMed 28939031 ↗
  • 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. PubMed 29529664 ↗
  • 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. PubMed 26150264 ↗
  • 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. PubMed 29310920 ↗
  • 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. PubMed 30454867 ↗
  • 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. PubMed 30234627 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06838455
Lead sponsor
Colorado Joint Replacement
Responsible party
Jason Jennings (Orthopedic Surgeon, Colorado Joint Replacement) — Principal investigator
First posted
Feb 20, 2025
Start date
Feb 2025 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Feb 20, 2025

Study contacts

Makenna Hemmerle, MS
Contact
makenna.hemmerle@adventhealth.com
3032602951
Dennis Douglas, MD
principal investigator · Colorado Joint Replacement

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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