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SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses (SPECT-PROTMA)

Primary Purpose

Arthropathy of Hip

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Total hip arthroplasty using the Exeter V40 cemented femoral stem

Total hip arthroplasty using the Müller Straight Stem

About this trial

This is an interventional diagnostic trial for Arthropathy of Hip focused on measuring Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hospital Universitari de BellvitgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thick-Layer Technique

Thin-Layer Technique (French Paradox)

Arm Description

Total hip arthroplasty using the Exeter V40 cemented femoral stem [Stryker Orthopaedics, Mahwah, New Jersey].

Total hip arthroplasty using the Müller Straight Stem [Zimmer, Winterthur, Switzerland].

Outcomes

Primary Outcome Measures

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

Alignment angles in the plain radiography and in the CT scan study.

Secondary Outcome Measures

Axial displacement in the plain radiography and in the CT Scan study.

Harris Radiographic Classification of Loosening Risk.

Harris Hip Score

Merle d'Aubigné Score

WOMAC Index Score

EuroQoL-5D-3L questionnaire score

Permission for this instruments' use has been granted by the EuroQoL Office.

Full Information

NCT ID

NCT05010733

First Posted

August 11, 2021

Last Updated

March 14, 2022

Sponsor

Daniel Rodriguez Perez

Collaborators

Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut

1. Study Identification

Unique Protocol Identification Number

NCT05010733

Brief Title

SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

Acronym

SPECT-PROTMA

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniel Rodriguez Perez

Collaborators

Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy of Hip

Keywords

Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking Description

After assignment to interventions (Exeter V40 cemented femoral stem or Müller THA), participant and surgeon team will be aware of the type of cemented stem prosthesis allocated. Since after randomization this is an open-label study, emergency unblinding does not apply. Data analysts will be blinded. Personal patient data will be coded and dissociated, so that the patient to whom they correspond is not recognizable. Consecutive numbers will be assigned as they are enrolled in the study, and these numbers (or codes) will be used in the eCRF, rather than personal data.

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thick-Layer Technique

Arm Type

Experimental

Arm Description

Total hip arthroplasty using the Exeter V40 cemented femoral stem [Stryker Orthopaedics, Mahwah, New Jersey].

Arm Title

Thin-Layer Technique (French Paradox)

Arm Type

Active Comparator

Arm Description

Total hip arthroplasty using the Müller Straight Stem [Zimmer, Winterthur, Switzerland].

Intervention Type

Device

Intervention Name(s)

Total hip arthroplasty using the Exeter V40 cemented femoral stem

Other Intervention Name(s)

Total hip arthroplasty using the Thick-Layer Technique

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Total hip arthroplasty using the Müller Straight Stem

Other Intervention Name(s)

Total hip arthroplasty using the Thin-Layer Technique (French Paradox)

Intervention Description

Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.

Primary Outcome Measure Information:

Title

Number of counts per image set in the SPECT study

Description

Counts per image: unit of measure defined as the number of photons captured by the gamma camera, which represent the radiopharmaceutical uptake

Time Frame

24 months after surgery

Title

Alignment angles in the plain radiography and in the CT scan study.

Time Frame

24 months after surgery

Secondary Outcome Measure Information:

Title

Axial displacement in the plain radiography and in the CT Scan study.

Time Frame

24 months after surgery

Title

Harris Radiographic Classification of Loosening Risk.

Time Frame

24 months after surgery

Title

Harris Hip Score

Time Frame

24 months after surgery

Title

Merle d'Aubigné Score

Time Frame

24 months after surgery

Title

WOMAC Index Score

Time Frame

24 months after surgery

Title

EuroQoL-5D-3L questionnaire score

Description

Permission for this instruments' use has been granted by the EuroQoL Office.

Time Frame

24 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel R Pérez, MD

Phone

+34932607500

d.rodriguez.perez@bellvitgehospital.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel R Pérez, MD

Organizational Affiliation

Orthopedic Surgeon Specialized in Hip Arthroplasty

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari de Bellvitge

City

L'Hospitalet De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel R Pérez, MD

Phone

+34932607500

d.rodriguez.perez@bellvitgehospital.cat

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

background

Citation

Lopez franco, M. P. Yendo al hospital. Diagnóstico por la imagen. Sociedad Española de Proteccion Radiológica 2006.

Results Reference

background

PubMed Identifier

24052089

Citation

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.

Results Reference

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PubMed Identifier

20190303

Citation

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.

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Citation

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Results Reference

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PubMed Identifier

7118973

Citation

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.

Results Reference

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PubMed Identifier

5783851

Citation

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.

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PubMed Identifier

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Citation

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.

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Citation

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Citation

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Citation

Rodriguez D, Carnaval T, Del Carmen M, Palomar-Munoz A, Cortes-Romera M, Agullo JL, Videla S. SPECT-CT metabolic and morphological study of 2 types of cemented hip stem prostheses in primary total hip arthroplasty patients: A protocol for a randomized controlled clinical trial (SPECT-PROTMA). Medicine (Baltimore). 2021 Dec 30;100(52):e28299. doi: 10.1097/MD.0000000000028299.

Results Reference

derived

Links:

URL

https://www.sepr.es/profesionales/descargables/download/82-area-medica/4070-yendo-al-hospital-i-diagnostico-por-imagen-radiodiagnostico-y-medicina-nuclear

Description

Lopez franco, M. P. Yendo al hospital. Diagnóstico por la imagen. Sociedad Española de Proteccion Radiológica 2006.

URL

https://publications.jrc.ec.europa.eu/repository/handle/JRC72428

Description

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

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SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

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