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

NCT ID: NCT02447653

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-15
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxyapatite Coating

G7 HA Acetabular component will be implanted

Group Type: EXPERIMENTAL

G7 HA Acetabular Component

Intervention Type: DEVICE

G7 HA Acetabular Component

Plasma Porous Spray

G7 PPS Acetabular component will be implanted

Group Type: ACTIVE_COMPARATOR

G7 PPS Acetabular Component

Intervention Type: DEVICE

G7 PPS Acetabular Component

Interventions

G7 HA Acetabular Component

G7 HA Acetabular Component

Intervention Type: DEVICE

G7 PPS Acetabular Component

G7 PPS Acetabular Component

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with osteoarthritis who are candidates for a primary total hip replacement with uncemented acetabular and femoral components as determined by the surgeon.

2. Male and non-pregnant female patient aged 18 to 70.

3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria

1. Patients requiring total hip replacement surgery for a fresh hip fracture.

2. Patients with inflammatory arthritis

3. Patients with metabolic bone disease or taking drugs that affect bone turnover. 4 .Patients requiring revision surgery of a previously implanted total hip replacement system or patients requiring a conversion surgery from a previous fracture fixation or hip fusion.

5. Patients with presence of malignancy in the area of the involved hip joint. 6. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.

7. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Liu

Role: PRINCIPAL_INVESTIGATOR

Gold Coast Centre for Bone and Joint Surgery

Locations

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Countries

Australia

Other Identifiers

BMETAU09

Identifier Type: -

Identifier Source: org_study_id