Observational Study of the Development of Low Back Pain After Total Hip Arthroplasty.

Low Back Pain Clinical Trial

Official title:

Development of Low Back Pain After Total Hip Arthroplasty.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647629
• Other study ID #: PI21/346
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 618
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Hip
• Back Pain
• Hip Osteoarthritis
• Low Back Pain
• Osteoarthritis, Hip

Intervention

Procedure:
• Total hip arthroplasty
hip prosthesis surgery

Locations

Country	Name	City	State
Spain	Francisco José Gallego Peñalver	Valencia
Spain	Francisco José Gallego Peñalver	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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 20 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of patients with low back pain	First episode of low back pain	10 years