Clinical trial NCT05010733: SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses
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
Overall status: UNKNOWN
Phase: NA
Conditions: Arthropathy of Hip
Keywords: Hip Arthroplasty
French Paradox
Thick-layer
SPECT
Metabolic changes
CT scan
Morphological changes
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
name: Institut Català de la Salut
First posted: 2021-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of counts per image set in the SPECT study
timeFrame: 24 months after surgery
measure: Alignment angles in the plain radiography and in the CT scan study.
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Axial displacement in the plain radiography and in the CT Scan study.
timeFrame: 24 months after surgery
measure: Harris Radiographic Classification of Loosening Risk.
timeFrame: 24 months after surgery
measure: Harris Hip Score
timeFrame: 24 months after surgery
measure: Merle d'Aubigné Score
timeFrame: 24 months after surgery
measure: WOMAC Index Score
timeFrame: 24 months after surgery
measure: EuroQoL-5D-3L questionnaire score
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Orthopedic Surgeon Specialized in Hip Arthroplasty
name: Daniel R Pérez, MD
role: PRINCIPAL_INVESTIGATOR
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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.