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

• Sponsor: Universidad de Zaragoza (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05647629
• Collaborator: (none)
• Enrollment: 618
• Locations: 2
• Anticipated Duration (Months): 43
• Patients Per Site: 309
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Hip Osteoarthritis; Arthropathy of Hip	Procedure: Total hip arthroplasty

Study Design

• Study Type: Observational
• Anticipated Enrollment: 618 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Development of Low Back Pain After Total Hip Arthroplasty.
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: May 1, 2025

Outcome Measures

Primary Outcome Measures

1. Prevalence of patients with low back pain [10 years]

   First episode of low back pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Francisco José Gallego Peñalver	Valencia		Spain	46015
2	Francisco José Gallego Peñalver	Zaragoza		Spain	50009

Sponsors and Collaborators

• Universidad de Zaragoza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Francisco José Gallego Peñalver, Principal Investigator, Universidad de Zaragoza
• ClinicalTrials.gov Identifier: NCT05647629
• Other Study ID Numbers: PI21/346
• First Posted: Dec 12, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Francisco José Gallego Peñalver, Principal Investigator, Universidad de Zaragoza: Pain; Low back pain; Psoas muscle; Hip arthroplasty
• Additional relevant MeSH terms: Osteoarthritis, Hip; Back Pain; Low Back Pain

Study Results

No Results Posted as of Dec 16, 2022