NCT05773261

Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.

Detailed description

The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear. Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial. In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DEVICE	MobilLINK TrabecuLINK cup	THA with MobilLINK TrabecuLINK cup and LCU stem
DEVICE	Pinnacle Gription cup	THA with Pinnacle Gription cup and Coral stem

Timeline

• Start date: 2022-09-09
• Primary completion: 2026-09-09
• Completion: 2039-09-09
• First posted: 2023-03-17
• Last updated: 2023-12-08

Locations

1 site across 1 country: Sweden