Observational Study of the Development of Low Back Pain A... | NCT05647629

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

NCT05647629

Sponsor

Universidad de Zaragoza

Status

Completed

Last Update Posted

May 4, 2026Actual

Enrollment

618Actual

Phase

Not provided

Conditions

Low Back Pain
Hip Osteoarthritis
Arthropathy of Hip

Interventions

Total hip arthroplasty

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Feb 23, 2025Actual

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Dec 2, 2022

First Posted Date

Dec 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francisco José Gallego Peñalver, Principal Investigator, Universidad de ZaragozaPrincipal Investigator

Lead Sponsor

Universidad de ZaragozaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

618Actual

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty	Procedure	hip prosthesis surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of patients with low back pain	First episode of low back pain	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Francisco José Gallego Peñalver		Valencia	Valencia	46015	Spain
Francisco José Gallego Peñalver

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32361852	Background	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.
27054031	Background	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.

ID	Term
D017116	Low Back Pain
D015207	Osteoarthritis, Hip
D010146	Pain

ID	Term
D001416	Back Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative