- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05647629
Observational Study of the Development of Low Back Pain After Total Hip Arthroplasty.
April 27, 2026 updated by: Francisco José Gallego Peñalver, Universidad de Zaragoza
Development of Low Back Pain After Total Hip Arthroplasty.
The investigators are going to observe the appearance of low back pain in patients who have undergone hip prosthesis surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
618
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Valencia
-
Valencia, Valencia, Spain, 46015
- Francisco José Gallego Peñalver
-
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Zaragoza
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Zaragoza, Zaragoza, Spain, 50009
- Francisco José Gallego Peñalver
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Population corresponding to Sector II of Zaragoza, Autonomous Community of Aragon, Spain.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of patients with low back pain
Time Frame: 10 years
|
First episode of low back pain
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Gallego-Penalver FJ, Romero-de-la-Higuera SB, Berdejo Arceiz V, Gomez Trullen EM. Low back pain after total hip arthroplasty: Long-term retrospective cohort study. Rehabilitacion (Madr). 2025 Jul-Sep;59(3):100928. doi: 10.1016/j.rh.2025.100928. Epub 2025 Aug 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
February 23, 2025
Study Registration Dates
First Submitted
December 2, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Actual)
December 12, 2022
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Back Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Low Back Pain
- Osteoarthritis, Hip
- Surgical Procedures, Operative
- Arthroplasty, Replacement
- Arthroplasty
- Orthopedic Procedures
- Plastic Surgery Procedures
- Prosthesis Implantation
- Arthroplasty, Replacement, Hip
Other Study ID Numbers
- PI21/346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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