SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses (SPECT-PROTMA)

Daniel Rodriguez Perez

Status: Enrolling

Conditions: Arthropathy of Hip

Treatments: Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem; Device: Total hip arthroplasty using the Müller Straight Stem

Study type: Interventional

Funder types: Other

Identifiers

NCT05010733

HUB- COT-2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Thick-Layer Technique

Experimental group

Description:

Total hip arthroplasty using the Exeter V40 cemented femoral stem \[Stryker Orthopaedics, Mahwah, New Jersey\].

Treatment:

Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem

Thin-Layer Technique (French Paradox)

Active Comparator group

Description:

Total hip arthroplasty using the Müller Straight Stem \[Zimmer, Winterthur, Switzerland\].

Treatment:

Device: Total hip arthroplasty using the Müller Straight Stem