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

NCT ID: NCT05647629

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

618 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-05-01

Brief Summary

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

Detailed Description

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Conditions

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Low Back Pain Hip Osteoarthritis Arthropathy of Hip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Total hip arthroplasty

hip prosthesis surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Francisco José Gallego Peñalver

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Francisco José Gallego Peñalver

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Francisco José Gallego Peñalver

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Francisco José FJ Gallego Peñalver, Grade

Role: primary

34-656-967-180

Silvia Beatriz SB Romero de la Higuera, Grade

Role: backup

34-666-044-863

References

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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.

Reference Type BACKGROUND
PMID: 32361852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27054031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11130022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31118071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17541541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17966005 (View on PubMed)

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.

Reference Type RESULT
PMID: 24380773 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40763561 (View on PubMed)

Other Identifiers

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PI21/346

Identifier Type: -

Identifier Source: org_study_id

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