NCT05010733

SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Daniel Rodriguez Perez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthropathy of Hip

Interventions

Type	Name	Description
DEVICE	Total 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.
DEVICE	Total 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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-08-18
• Last updated: 2022-03-15

Locations

1 site across 1 country: Spain