Clinical trial NCT05647629: Observational Study of the Development of Low Back Pain After Total Hip Arthroplasty.
Official title: Development of Low Back Pain After Total Hip Arthroplasty.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Hip Osteoarthritis
Arthropathy of Hip
Keywords: Pain
Low back pain
Psoas muscle
Hip arthroplasty
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 618
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population corresponding to Sector II of Zaragoza, Autonomous Community of Aragon, Spain.

Brief summary: The investigators are going to observe the appearance of low back pain in patients who have undergone hip prosthesis surgery.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age and under 70 years of age, intervened by CTA due to OAC since January 1, 2010 and before January 1, 2021 and who have developed subsequent lumbar pathology.

Exclusion Criteria (relative/absolute):

* Under 18 years of age at the time of the intervention.
* Over 70 years of age at the time of surgery.
* Previous low back pain.
* Bilateral CTA.
* Previous lower limb or axial fracture.
* Dysmetria.
* Vertebral surgery prior to CTA.
* Scoliosis.
* Scheuermann's disease.
* Neoplasms affecting axial skeleton.
* Bone infections.
* Neurodegenerative disease.
* CTA secondary to fractures.
* CTA replacements.

Primary outcomes:
measure: Prevalence of patients with low back pain
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Francisco José Gallego Peñalver
city: Zaragoza
country: Spain
facility: Francisco José Gallego Peñalver
Study officials:
References:
citation: Mak D, Chisholm C, Davies AM, Botchu R, James SL. Psoas muscle atrophy following unilateral hip arthroplasty. Skeletal Radiol. 2020 Oct;49(10):1539-1545. doi: 10.1007/s00256-020-03447-3. Epub 2020 May 2.
citation: Morohashi I, Homma Y, Kanda A, Yamamoto Y, Obata H, Mogami A, Obayashi O, Kaneko K. Iliopsoas impingement after revision total hip arthroplasty treated with iliopsoas muscle transection. Ann Med Surg (Lond). 2016 Mar 10;7:30-3. doi: 10.1016/j.amsu.2016.03.004. eCollection 2016 May.
citation: Slater N, Singh R, Senasinghe N, Gore R, Goroszeniuk T, James D. Pressure monitoring of the femoral nerve during total hip replacement: an explanation for iatropathic palsy. J R Coll Surg Edinb. 2000 Aug;45(4):231-3.
citation: Zhu J, Li Y, Chen K, Xiao F, Shen C, Peng J, Chen X. Iliopsoas tendonitis following total hip replacement in highly dysplastic hips: a retrospective study. J Orthop Surg Res. 2019 May 22;14(1):145. doi: 10.1186/s13018-019-1176-z.
citation: Hessmann MH, Hubschle L, Tannast M, Siebenrock KA, Ganz R. [Irritation of the iliopsoas tendon after total hip arthroplasty]. Orthopade. 2007 Aug;36(8):746-51. doi: 10.1007/s00132-007-1094-3. German.
citation: Rasch A, Bystrom AH, Dalen N, Berg HE. Reduced muscle radiological density, cross-sectional area, and strength of major hip and knee muscles in 22 patients with hip osteoarthritis. Acta Orthop. 2007 Aug;78(4):505-10. doi: 10.1080/17453670710014158.
citation: Jorda Llona M, Perez Bocanegra E, Garcia-Mifsud M, Jimeno Bernad R, Ortiz Hernandez R, Castells Ayuso P. [Back school: a simple way to improve pain and postural behaviour]. An Pediatr (Barc). 2014 Aug;81(2):92-8. doi: 10.1016/j.anpedi.2013.11.018. Epub 2013 Dec 28. Spanish.