Not yet recruiting NCT06838455
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinopelvic mobility exercise.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA) of the Hip. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Spinopelvic 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.
Primary outcome measures
- Spinopelvic radiographic measurements [Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day.]
- Lumbar mobility [Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day]
- Spinopelvic mobility [Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day]
- Patient risk classification for THA instability [Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day]
Secondary outcome measures (7)
- Oswestry Disability Index score [Time frame: Baseline]
- Hip Society Score [Time frame: Baseline]
- Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) [Time frame: Baseline]
- The Veterans Rand 12-Item Health Survey scores (VR-12) [Time frame: Baseline]
- Use of medication for hip/back pain [Time frame: Baseline]
- Severity of hip arthritis [Time frame: Baseline]
- Adverse events [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Patients aged 18-90 scheduled for total hip arthroplasty
- Patients with primary hip osteoarthritis
- Patients with or without history of prior spinal injections
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29310920
Identifiers
NCT: NCT06838455 · 2279537