NCT02447653

Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA

A Randomised Controlled Study Comparing Hydroxyapatite (HA) Coating Versus Plasma Porous Spray in Press-fit Acetabular Components Early Outcomes With Dual Energy X-ray Absorptiometry (DEXA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density. Clinical evaluations will be conducted .

Detailed description

The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density preoperatively and post-operatively at 6 weeks, 12 weeks, 26 weeks, and 12 months for both the treated and contralateral hip joint. Clinical evaluations will be conducted preoperatively, and postoperatively at 6, 12, 26 weeks, 12 months and 24 months.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	G7 HA Acetabular Component	G7 HA Acetabular Component
DEVICE	G7 PPS Acetabular Component	G7 PPS Acetabular Component

Timeline

• Start date: 2016-07-15
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2015-05-19
• Last updated: 2022-01-28

Locations

1 site across 1 country: Australia