SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Arthropathy of Hip

Intervention / Treatment
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* Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem
* Device: Total hip arthroplasty using the Müller Straight Stem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thick-Layer Technique<br>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<br>* 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.<br>* Other names: Total hip arthroplasty using the Thick-Layer Technique;|
| Active Comparator: Thin-Layer Technique (French Paradox)<br>Total hip arthroplasty using the Müller Straight Stem [Zimmer, Winterthur, Switzerland]. | Device: Total hip arthroplasty using the Müller Straight Stem<br>* Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.<br>* Other names: Total hip arthroplasty using the Thin-Layer Technique (French Paradox);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Permission for this instruments' use has been granted by the EuroQoL Office. | 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes