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

NCT02447653 | Completed

• 1 other identifier: BMETAU09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Bone Remodelling (DEXA analysis)

  DEXA analysis

  12 months

Secondary Outcomes (2)

• Clinical (Harris Hip Score)

  24 months

• Clinical (Oxford Hip Score)

  24 months

Study Arms (2)

Hydroxyapatite Coating

EXPERIMENTAL

G7 HA Acetabular component will be implanted

Device: G7 HA Acetabular Component

Plasma Porous Spray

ACTIVE COMPARATOR

G7 PPS Acetabular component will be implanted

Device: G7 PPS Acetabular Component

Interventions

G7 HA Acetabular Component DEVICE

G7 HA Acetabular Component

Hydroxyapatite Coating

G7 PPS Acetabular Component DEVICE

G7 PPS Acetabular Component

Plasma Porous Spray

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with osteoarthritis who are candidates for a primary total hip replacement with uncemented acetabular and femoral components as determined by the surgeon.
• Male and non-pregnant female patient aged 18 to 70.
• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

You may not qualify if:

• Patients requiring total hip replacement surgery for a fresh hip fracture.
• Patients with inflammatory arthritis
• 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David Liu

  Gold Coast Centre for Bone and Joint Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 19, 2015
• Study Start: July 15, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)