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)
| Registry | NCT05010733, acronym SPECT-PROTMA |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
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| Enrollment | 16 (Estimated) |
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| Sponsor | Daniel Rodriguez Perez (Other); collaborators: Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut |
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| Conditions | Arthropathy of Hip |
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| Interventions | Total hip arthroplasty using the Exeter V40 cemented femoral stem, Total hip arthroplasty using the Müller Straight Stem (Device) |
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| Dates | start 2022-01-01, primary completion 2023-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2021-08-18, last updated 2022-03-15 |
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| Locations | 1 site in Spain |
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Related Papers Related Patents Related Grants Related Experts
All trials for Arthropathy of Hip All trials of Total hip arthroplasty using the Exeter V40 cemented femoral stem All trials of Total hip arthroplasty using the Müller Straight Stem
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Thick-Layer Technique | Experimental | Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem | Total 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 Stem | Total hip arthroplasty using the Müller Straight Stem \[Zimmer, Winterthur, Switzerland\]. |
- Total hip arthroplasty using the Exeter V40 cemented femoral stem (Device), also known as 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 Stem (Device), also known as 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.
+Outcome measures
Primary outcomes
- Number of counts per image set in the SPECT study [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. [24 months after surgery]
Secondary outcomes
- 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]
- EuroQoL-5D-3L questionnaire score [24 months after surgery]: Permission for this instruments' use has been granted by the EuroQoL Office.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat, Barcelona | Spain | Recruiting |
+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.
- Results publication: 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
- Results publication: 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
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- Results publication: 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
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- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
+Investigators
- Daniel R Pérez, MD, Principal investigator, Orthopedic Surgeon Specialized in Hip Arthroplasty