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

An observational study of Low Back Pain and Hip Osteoarthritis, run by Universidad de Zaragoza at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Low Back Pain, Hip Osteoarthritis, Arthropathy of Hip
What is being tested?: Total hip arthroplasty
Type of treatment: Surgery or procedure
How many people: 618 participants
Where: 2 sitesSpain
Study dates: 1 Oct 2021to 23 Feb 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

Vertebral surgery prior to CTA.
Scoliosis.
Scheuermann's disease.
Neoplasms affecting axial skeleton.
Bone infections.
Neurodegenerative disease.
CTA secondary to fractures.
CTA replacements.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Francisco José Gallego Peñalver
Valencia, Valencia, 46015
Francisco José Gallego Peñalver
Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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.

Conditions: Low Back Pain, Hip Osteoarthritis, Arthropathy of Hip
Being tested: Total hip arthroplasty
Keywords: Pain, Low back pain, Psoas muscle, Hip arthroplasty
Medical subject headings: Low Back Pain, Osteoarthritis, Hip, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total hip arthroplastyProcedure or surgery
hip prosthesis surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of patients with low back pain
First episode of low back pain
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202123 Feb 2025

First posted12 Dec 2022
Study start1 Oct 2021
Primary completion1 Dec 2022
Study completion23 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 618 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05647629
Sponsor's protocol ID: PI21/346
Status last verified: Feb 2025
First submitted: 2 Dec 2022
Last updated: 4 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 32361852
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.
PubMed 27054031
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.
PubMed 11130022
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.
PubMed 31118071
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.
PubMed 17541541
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.
PubMed 17966005
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.
PubMed 24380773
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.
PubMed 40763561

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Low Back Pain After Total Hip Arthroplasty.
ClinicalTrials.gov ID: NCT05647629
Acronym / sponsor ID: PI21/346
Conditions: Low Back Pain, Hip Osteoarthritis, Arthropathy of Hip
Keywords: Pain, Low back pain, Psoas muscle, Hip arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 618 participants (actual)
Lead sponsor: Universidad de ZaragozaUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 23 Feb 2025 (actual)
First posted: 12 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Population corresponding to Sector II of Zaragoza, Autonomous Community of Aragon, Spain.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Total hip arthroplastyhip prosthesis surgery	Procedure or surgery	–

Primary outcome

Prevalence of patients with low back pain
Time frame: 10 years
First episode of low back pain

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Background: PubMed 32361852Mak 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.
Background: PubMed 27054031Morohashi 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.
Background: PubMed 11130022Slater 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.
Background: PubMed 31118071Zhu 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.
Background: PubMed 17541541Hessmann 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.
Background: PubMed 17966005Rasch 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.
Results publication: PubMed 24380773Jorda 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.
Derived from this study: PubMed 40763561Gallego-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.
Individual participant dataSharing planned: Undecided

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain and Hip Osteoarthritis, run by Universidad de Zaragoza at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of patients with low back pain (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05647629, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.