Efficacité des exercices thérapeutiques sur la mobilité spinopelvienne
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Denver, Colorado, États-Unis, 80210
- AdventHealth Medical Group Colorado Joint Replacement
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Spinopelvic Exercise
Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Spinopelvic radiographic measurements
Délai: 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. |
Change from baseline to up to 1 hour after spinopelvic exercises same day.
|
|
Lumbar mobility
Délai: 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. |
Change from baseline to up to 1 hour after spinopelvic exercises same day
|
|
Spinopelvic mobility
Délai: 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. |
Change from baseline to up to 1 hour after spinopelvic exercises same day
|
|
Patient risk classification for THA instability
Délai: 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) |
Change from baseline to up to 1 hour after spinopelvic exercises same day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oswestry Disability Index score
Délai: 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. |
Baseline
|
|
Hip Society Score
Délai: Baseline
|
Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes. |
Baseline
|
|
Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Délai: Baseline
|
Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes. |
Baseline
|
|
The Veterans Rand 12-Item Health Survey scores (VR-12)
Délai: 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. |
Baseline
|
|
Use of medication for hip/back pain
Délai: Baseline
|
Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement. |
Baseline
|
|
Severity of hip arthritis
Délai: 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. |
Baseline
|
|
Adverse events
Délai: Day 1
|
Any adverse events sustained from therapeutic exercises |
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dennis Douglas, MD, Colorado Joint Replacement
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2279537
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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