SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

Arthropathy of Hip Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010733
• Other study ID #: HUB- COT-2020-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Hospital Universitari de Bellvitge
• Contact: Daniel R Pérez, MD
• Phone: +34932607500
• Email: d.rodriguez.perez[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Intervention

Device:
• Total hip arthroplasty using the Exeter V40 cemented femoral stem
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 Stem
Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Daniel Rodriguez Perez	Institut Català de la Salut, Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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. Review. — View 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: 10.1302/030 — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View 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. — View 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. — View 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

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

Merle D'Aubigné R. [Numerical classification of the function of the hip. 1970]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(6):371-4. French. — View Citation

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. Review. — View Citation

Øvre S, Sandvik L, Madsen JE, Røise O. Comparison of distribution, agreement and correlation between the original and modified Merle d'Aubigné-Postel Score and the Harris Hip Score after acetabular fracture treatment: moderate agreement, high ceiling effe — View Citation

Roos EM, Klässbo 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. — View Citation

Son HJ, Jeong YJ, Yoon HJ, Wang L, Kim HJ, Park JH, Kang DY. Visual Pattern and Serial Quantitation of (18)F-Sodium Fluoride PET/CT in Asymptomatic Patients After Hip and Knee Arthroplasty. Nucl Med Mol Imaging. 2016 Dec;50(4):308-321. Epub 2016 Jul 13. — View Citation

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. Review. — View Citation

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 pr — View Citation

Venesmaa P, Vanninen E, Miettinen H, Kröger H. Periprosthetic bone turnover after primary total hip arthroplasty measured by single-photon emission computed tomography. Scand J Surg. 2012;101(4):241-8. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Alignment angles in the plain radiography and in the CT scan study.		24 months after surgery
Secondary	Axial displacement in the plain radiography and in the CT Scan study.		24 months after surgery
Secondary	Harris Radiographic Classification of Loosening Risk.		24 months after surgery
Secondary	Harris Hip Score		24 months after surgery
Secondary	Merle d'Aubigné Score		24 months after surgery
Secondary	WOMAC Index Score		24 months after surgery
Secondary	EuroQoL-5D-3L questionnaire score	Permission for this instruments' use has been granted by the EuroQoL Office.	24 months after surgery

External Links

•   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.