SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

NCT05010733 | Unknown DMC

• 1 other identifier: HUB- COT-2020-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Hip

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  24 months after surgery

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

  24 months after surgery

Secondary Outcomes (6)

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

  24 months after surgery

• Harris Radiographic Classification of Loosening Risk.

  24 months after surgery

• Harris Hip Score

  24 months after surgery

• Merle d'Aubigné Score

  24 months after surgery

• WOMAC Index Score

  24 months after surgery

Study Arms (2)

Thick-Layer Technique

EXPERIMENTAL

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

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 \[Zimmer, Winterthur, Switzerland\].

Device: Total hip arthroplasty using the Müller Straight Stem

Interventions

Total hip arthroplasty using the Exeter V40 cemented femoral stem DEVICE

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.

Also known as: Total hip arthroplasty using the Thick-Layer Technique

Thick-Layer Technique

Total hip arthroplasty using the Müller Straight Stem DEVICE

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

Also known as: Total hip arthroplasty using the Thin-Layer Technique (French Paradox)

Thin-Layer Technique (French Paradox)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Rodriguez Perez: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Institut Català de la Salut: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (18)

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24052089 RESULT

• 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.

  PMID: 20190303 RESULT

• 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.

  PMID: 10109801 RESULT

• 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.

  PMID: 7118973 RESULT

• 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.

  PMID: 5783851 RESULT

• 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.

  PMID: 2149773 RESULT

• 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.

  PMID: 31275942 RESULT

• 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.

  PMID: 16470432 RESULT

• 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.

  PMID: 10503556 RESULT

• 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.

  PMID: 27994686 RESULT

• 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.

  PMID: 24047953 RESULT

• 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.

  PMID: 27262701 RESULT

• 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.

  PMID: 23238498 RESULT

• Yamane T, Kuji I, Seto A, Matsunari I. Quantification of osteoblastic activity in epiphyseal growth plates by quantitative bone SPECT/CT. Skeletal Radiol. 2018 Jun;47(6):805-810. doi: 10.1007/s00256-017-2861-9. Epub 2018 Jan 11.

  PMID: 29327129 RESULT

• Yang Z, Reed T, Longino BH. Bone Scintigraphy SPECT/CT Evaluation of Mandibular Condylar Hyperplasia. J Nucl Med Technol. 2016 Mar;44(1):49-51. doi: 10.2967/jnmt.115.158691. Epub 2015 Jun 25.

  PMID: 26111714 RESULT

• 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.

  PMID: 34967362 DERIVED

Related Links

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

Study Officials

• Daniel R Pérez, MD

  Orthopedic Surgeon Specialized in Hip Arthroplasty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel R Pérez, MD

CONTACT

+34932607500; d.rodriguez.perez@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)