SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

Daniel Rodriguez Perez16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Arthropathy of Hip

Interventions

Total hip arthroplasty using the Exeter V40 cemented femoral stemDEVICE

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 StemDEVICE

Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

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