NCT05647629

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
618

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2025

Completed
Last Updated

May 4, 2026

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

December 2, 2022

Last Update Submit

April 27, 2026

Conditions

Low Back PainHip OsteoarthritisArthropathy of Hip

Keywords

PainLow back painPsoas muscleHip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Prevalence of patients with low back pain

    First episode of low back pain

    10 years

Interventions

Total hip arthroplastyPROCEDURE

hip prosthesis surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population corresponding to Sector II of Zaragoza, Autonomous Community of Aragon, Spain.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Francisco José Gallego Peñalver

Valencia, Valencia, 46015, Spain

Location

Francisco José Gallego Peñalver

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (8)

  • 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.

    PMID: 32361852BACKGROUND

  • 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.

    PMID: 27054031BACKGROUND

  • 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.

    PMID: 11130022BACKGROUND

  • 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.

    PMID: 31118071BACKGROUND

  • 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.

    PMID: 17541541BACKGROUND

  • 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.

    PMID: 17966005BACKGROUND

  • 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.

    PMID: 24380773RESULT

  • 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.

    PMID: 40763561DERIVED

MeSH Terms

Conditions

Low Back PainOsteoarthritis, HipPain

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

February 23, 2025

Last Updated

May 4, 2026

Record last verified: 2025-02

Locations

ES(2)