Arthropathy of Hip
Conditions
Keywords
Hip Arthroplasty, French Paradox, Thick-layer, SPECT, Metabolic changes, CT scan, Morphological changes
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.
Interventions
DEVICETotal 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.
DEVICETotal 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.
Sponsors
Institut d'Investigació Biomèdica de Bellvitge
Institut Català de la Salut
Daniel Rodriguez Perez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 24 months after surgery | — |
| Merle d'Aubigné Score | 24 months after surgery | — |
| Axial displacement in the plain radiography and in the CT Scan study. | 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. |
| WOMAC Index Score | 24 months after surgery | — |
| Harris Radiographic Classification of Loosening Risk. | 24 months after surgery | — |
Countries
Spain
Contacts
Primary ContactDaniel R Pérez, MD
Outcome results
None listed