Arthropathy of HipSPECT-PROTMANCT05010733

SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

A study testing Total hip arthroplasty using the Exeter V40 cemented femoral stem and Total hip arthroplasty using the Müller Straight Stem in people with Arthropathy of Hip, run by Daniel Rodriguez Perez at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Single center, pilot, randomized, controlled clinical trial to assess metabolic and morphological images between two types of cemented stem prostheses in patients undergoing total hip arthroplasty surgery during a 2-year follow up period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthropathy of Hip
What is being tested?: Total hip arthroplasty using the Exeter V40 cemented femoral stem and Total hip arthroplasty using the Müller Straight Stem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSpain
Study dates: 1 Jan 2022to 31 Dec 2024
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients ≥ 18 years-old
both genders
patients undergoing a primary total hip arthroplasty surgery with implantation of a cemented prosthesis (Exeter hip stem model or Müller straight stem model)
patients with a diagnosis of hip osteoarthritis, operated by the Orthopedic Surgery and Traumatology Department at the Bellvitge University Hospital
patients who signed the written informed consent.

Who cannot join

patients allergic to 99mTc-MDP radiopharmaceutical
patients with claustrophobia
patients with a background of an active septic process
patients with a postoperative septic complication
patients periprosthetic fracture or misalignment of the prosthetic component
patients who have a total hip prosthetic implanted due to a subcapital femoral fracture

Trial locations and contacts

1 site in 1 country.

Daniel R Pérez, MD contact

+34932607500

d.rodriguez.perez@bellvitgehospital.cat

Spain1 site, 1 recruiting

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Daniel R Pérez, MD, +34932607500, d.rodriguez.perez@bellvitgehospital.cat
Recruiting

Other trials in Spain

About this study

Official title: SPECT-CT Metabolic and Morphological Study of Two Types of Cemented Hip Stem Protheses in Primary Total Hip Arthroplasty Patients: A Randomized Controlled Clinical Trial (SPECT-PROTMA)

Read the detailed description

Single center, pilot, controlled clinical trial to assess metabolic and morphological images of patients undergoing total hip arthroplasty surgery randomized to the thick layer technique (Exeter hip stem model) or to the "French paradox" technique (Müller straight stem model).

Participants will be performed a plain radiography and a SPECT-CT at 3, 6, 12 and 24 months of the intervention. SPECT-CTs will be performed in addition to the usual medical care complementary imaging exams. The SPECT will require the administration of the 99mTechnetium-methylene diphosphonate (99mTc-MDP) radiopharmaceutical (useful to assess bone metabolism) and its combination with a CT scan (SPECT-CT) allows a combined metabolic and morphological study.

Conditions: Arthropathy of Hip
Being tested: Total hip arthroplasty using the Exeter V40 cemented femoral stem, Total hip arthroplasty using the Müller Straight Stem
Keywords: Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes

What participants receive

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

Total hip arthroplasty using the Exeter V40 cemented femoral stemDevice
Also called Total hip arthroplasty using the Thick-Layer Technique
Consists of applying a cement layer of at least 2 millimeters surrounding an undersized prosthetic stem, so that this layer of cement fits between the femoral medullary canal and the prosthetic's femoral stem.
Total hip arthroplasty using the Müller Straight StemDevice
Also called Total hip arthroplasty using the Thin-Layer Technique (French Paradox)
Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.

Study groups in NCT05010733
Study group	Role	What they receive
Thick-Layer Technique	Experimental	Total hip arthroplasty using the Exeter V40 cemented femoral stem [Stryker Orthopaedics, Mahwah, New Jersey]. Receives: Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem
Thin-Layer Technique (French Paradox)	Active comparator	Total hip arthroplasty using the Müller Straight Stem [Zimmer, Winterthur, Switzerland]. Receives: Device: Total hip arthroplasty using the Müller Straight Stem

What is being measured

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

Number of counts per image set in the SPECT study
Counts per image: unit of measure defined as the number of photons captured by the gamma camera, which represent the radiopharmaceutical uptake
Measured: 24 months after surgery
Alignment angles in the plain radiography and in the CT scan study.
Measured: 24 months after surgery

Secondary outcomes (6)

Axial displacement in the plain radiography and in the CT Scan study.
Measured: 24 months after surgery
Harris Radiographic Classification of Loosening Risk.
Measured: 24 months after surgery
Harris Hip Score
Measured: 24 months after surgery
Merle d'Aubigné Score
Measured: 24 months after surgery
WOMAC Index Score
Measured: 24 months after surgery
EuroQoL-5D-3L questionnaire score
Permission for this instruments' use has been granted by the EuroQoL Office.
Measured: 24 months after surgery

Timeline

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

1 Jan 202231 Dec 2024

First posted18 Aug 2021
Study start1 Jan 2022
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Arthropathy of HipStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: An anonymized list will be provided to the Biostatistics Department, who will randomly assign patients to a type of surgical intervention using a computer-generated randomization sequence. The randomization will be carried out previously to the surgery based on REDCap systems.
Masking: None (open label)
Enrolment: 16 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05010733
Sponsor's protocol ID: HUB- COT-2020-01
Acronym: SPECT-PROTMA
Status last verified: Mar 2022
First submitted: 11 Aug 2021
Last updated: 15 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Holzwarth U, Cotogno G; Total hip arthroplasty: State of the art, prospects and challenges. EUR 25378 EN. Luxembourg (Luxembourg): Publications Office of the European Union; 2012. JRC72428
Lopez franco, M. P. Yendo al hospital. Diagnóstico por la imagen. Sociedad Española de Proteccion Radiológica 2006.
Brix G, Nekolla EA, Borowski M, Nosske D. Radiation risk and protection of patients in clinical SPECT/CT. Eur J Nucl Med Mol Imaging. 2014 May;41 Suppl 1:S125-36. doi: 10.1007/s00259-013-2543-3. Epub 2013 Sep 20.
PubMed 24052089
El Masri F, Kerboull L, Kerboull M, Courpied JP, Hamadouche M. Is the so-called 'French paradox' a reality?: long-term survival and migration of the Charnley-Kerboull stem cemented line-to-line. J Bone Joint Surg Br. 2010 Mar;92(3):342-8. doi: 10.1302/0301-620X.92B3.23151.
PubMed 20190303
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801
Harris WH, McCarthy JC Jr, O'Neill DA. Femoral component loosening using contemporary techniques of femoral cement fixation. J Bone Joint Surg Am. 1982 Sep;64(7):1063-7.
PubMed 7118973
Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
PubMed 5783851
Merle D'Aubigne R. [Numerical classification of the function of the hip. 1970]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(6):371-4. No abstract available. French.
PubMed 2149773
Mushtaq N, To K, Gooding C, Khan W. Radiological Imaging Evaluation of the Failing Total Hip Replacement. Front Surg. 2019 Jun 18;6:35. doi: 10.3389/fsurg.2019.00035. eCollection 2019.
PubMed 31275942
Ovre S, Sandvik L, Madsen JE, Roise O. Comparison of distribution, agreement and correlation between the original and modified Merle d'Aubigne-Postel Score and the Harris Hip Score after acetabular fracture treatment: moderate agreement, high ceiling effect and excellent correlation in 450 patients. Acta Orthop. 2005 Dec;76(6):796-802. doi: 10.1080/17453670510045390.
PubMed 16470432
Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562.
PubMed 10503556
Son HJ, Jeong YJ, Yoon HJ, Wang L, Kim HJ, Park JH, Kang DY. Visual Pattern and Serial Quantitation of 18F-Sodium Fluoride PET/CT in Asymptomatic Patients After Hip and Knee Arthroplasty. Nucl Med Mol Imaging. 2016 Dec;50(4):308-321. doi: 10.1007/s13139-016-0430-0. Epub 2016 Jul 13.
PubMed 27994686
Tam HH, Bhaludin B, Rahman F, Weller A, Ejindu V, Parthipun A. SPECT-CT in total hip arthroplasty. Clin Radiol. 2014 Jan;69(1):82-95. doi: 10.1016/j.crad.2013.08.003. Epub 2013 Sep 15.
PubMed 24047953
Van den Wyngaert T, Strobel K, Kampen WU, Kuwert T, van der Bruggen W, Mohan HK, Gnanasegaran G, Delgado-Bolton R, Weber WA, Beheshti M, Langsteger W, Giammarile F, Mottaghy FM, Paycha F; EANM Bone & Joint Committee and the Oncology Committee. The EANM practice guidelines for bone scintigraphy. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1723-38. doi: 10.1007/s00259-016-3415-4. Epub 2016 Jun 4.
PubMed 27262701
Venesmaa P, Vanninen E, Miettinen H, Kroger H. Periprosthetic bone turnover after primary total hip arthroplasty measured by single-photon emission computed tomography. Scand J Surg. 2012;101(4):241-8. doi: 10.1177/145749691210100404.
PubMed 23238498

Want to know more?

Daniel R Pérez, MD

+34932607500

d.rodriguez.perez@bellvitgehospital.cat

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 EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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All Arthropathy of Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SPECT-CT Metabolic and Morphological Study of Two Types of Cemented Hip Stem Protheses in Primary Total Hip Arthroplasty Patients: A Randomized Controlled Clinical Trial (SPECT-PROTMA)
ClinicalTrials.gov ID: NCT05010733
Acronym / sponsor ID: SPECT-PROTMA / HUB- COT-2020-01
Conditions: Arthropathy of Hip
Keywords: Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 16 participants (estimated)
Lead sponsor: Daniel Rodriguez PerezUniversity, hospital or other
Collaborators: Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut
Study start: 1 Jan 2022 (actual)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 18 Aug 2021 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: An anonymized list will be provided to the Biostatistics Department, who will randomly assign patients to a type of surgical intervention using a computer-generated randomization sequence. The randomization will be carried out previously to the surgery based on REDCap systems.

Arm	Type	Receives
Thick-Layer Technique	Experimental	Device: Total hip arthroplasty using the Exeter V40 cemented femoral stemTotal hip arthroplasty using the Exeter V40 cemented femoral stem [Stryker Orthopaedics, Mahwah, New Jersey].
Thin-Layer Technique (French Paradox)	Active comparator	Device: Total hip arthroplasty using the Müller Straight StemTotal hip arthroplasty using the Müller Straight Stem [Zimmer, Winterthur, Switzerland].

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

patients ≥ 18 years-old
both genders
patients undergoing a primary total hip arthroplasty surgery with implantation of a cemented prosthesis (Exeter hip stem model or Müller straight stem model)
patients with a diagnosis of hip osteoarthritis, operated by the Orthopedic Surgery and Traumatology Department at the Bellvitge University Hospital
patients who signed the written informed consent.

Key exclusion criteria (6 listed)

patients allergic to 99mTc-MDP radiopharmaceutical
patients with claustrophobia
patients with a background of an active septic process
patients with a postoperative septic complication
patients periprosthetic fracture or misalignment of the prosthetic component

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 arthroplasty using the Exeter V40 cemented femoral stemAlso: Total hip arthroplasty using the Thick-Layer TechniqueConsists of applying a cement layer of at least 2 millimeters surrounding an undersized prosthetic stem, so that this layer of cement fits between the femoral medullary canal and the prosthetic's femoral stem.	Device	Thick-Layer Technique
Total hip arthroplasty using the Müller Straight StemAlso: Total hip arthroplasty using the Thin-Layer Technique (French Paradox)Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.	Device	Thin-Layer Technique (French Paradox)

Primary outcome

Number of counts per image set in the SPECT study
Time frame: 24 months after surgery
Counts per image: unit of measure defined as the number of photons captured by the gamma camera, which represent the radiopharmaceutical uptake
Alignment angles in the plain radiography and in the CT scan study.
Time frame: 24 months after surgery

6 secondary outcomes

Axial displacement in the plain radiography and in the CT Scan study.
Time frame: 24 months after surgery
Harris Radiographic Classification of Loosening Risk.
Time frame: 24 months after surgery
Harris Hip Score
Time frame: 24 months after surgery
Merle d'Aubigné Score
Time frame: 24 months after surgery
WOMAC Index Score
Time frame: 24 months after surgery
EuroQoL-5D-3L questionnaire score
Time frame: 24 months after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
BackgroundHolzwarth U, Cotogno G; Total hip arthroplasty: State of the art, prospects and challenges. EUR 25378 EN. Luxembourg (Luxembourg): Publications Office of the European Union; 2012. JRC72428
BackgroundLopez franco, M. P. Yendo al hospital. Diagnóstico por la imagen. Sociedad Española de Proteccion Radiológica 2006.
Results publication: PubMed 24052089Brix G, Nekolla EA, Borowski M, Nosske D. Radiation risk and protection of patients in clinical SPECT/CT. Eur J Nucl Med Mol Imaging. 2014 May;41 Suppl 1:S125-36. doi: 10.1007/s00259-013-2543-3. Epub 2013 Sep 20.
Results publication: PubMed 20190303El Masri F, Kerboull L, Kerboull M, Courpied JP, Hamadouche M. Is the so-called 'French paradox' a reality?: long-term survival and migration of the Charnley-Kerboull stem cemented line-to-line. J Bone Joint Surg Br. 2010 Mar;92(3):342-8. doi: 10.1302/0301-620X.92B3.23151.
Results publication: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Results publication: PubMed 7118973Harris WH, McCarthy JC Jr, O'Neill DA. Femoral component loosening using contemporary techniques of femoral cement fixation. J Bone Joint Surg Am. 1982 Sep;64(7):1063-7.
Results publication: PubMed 5783851Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
Results publication: PubMed 2149773Merle D'Aubigne R. [Numerical classification of the function of the hip. 1970]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(6):371-4. No abstract available. French.
Results publication: PubMed 31275942Mushtaq N, To K, Gooding C, Khan W. Radiological Imaging Evaluation of the Failing Total Hip Replacement. Front Surg. 2019 Jun 18;6:35. doi: 10.3389/fsurg.2019.00035. eCollection 2019.
Results publication: PubMed 16470432Ovre S, Sandvik L, Madsen JE, Roise O. Comparison of distribution, agreement and correlation between the original and modified Merle d'Aubigne-Postel Score and the Harris Hip Score after acetabular fracture treatment: moderate agreement, high ceiling effect and excellent correlation in 450 patients. Acta Orthop. 2005 Dec;76(6):796-802. doi: 10.1080/17453670510045390.
Results publication: PubMed 10503556Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562.
Results publication: PubMed 27994686Son HJ, Jeong YJ, Yoon HJ, Wang L, Kim HJ, Park JH, Kang DY. Visual Pattern and Serial Quantitation of 18F-Sodium Fluoride PET/CT in Asymptomatic Patients After Hip and Knee Arthroplasty. Nucl Med Mol Imaging. 2016 Dec;50(4):308-321. doi: 10.1007/s13139-016-0430-0. Epub 2016 Jul 13.
Lopez franco, M. P. Yendo al hospital. Diagnóstico por la imagen. Sociedad Española de Proteccion Radiológica 2006.Link provided by the sponsor.
Holzwarth U, Cotogno G; Total hip arthroplasty: State of the art, prospects and challenges. EUR 25378 EN. Luxembourg (Luxembourg): Publications Office of the European Union; 2012. JRC72428Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Arthropathy of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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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.

Daniel R Pérez, MD contact

+34932607500

d.rodriguez.perez@bellvitgehospital.cat

Daniel R Pérez, MD principal investigator

Orthopedic Surgeon Specialized in Hip Arthroplasty

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Daniel R Pérez, MD (+34932607500, d.rodriguez.perez@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of counts per image set in the SPECT study (time frame: 24 months after surgery). The study lists 2 primary outcomes in all. 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 NCT05010733, which also lists 18 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 15 Mar 2022.