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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
G7 HA Acetabular Component
G7 PPS Acetabular Component
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Greenslopes Private Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydroxyapatite Coating

Plasma Porous Spray

Arm Description

G7 HA Acetabular component will be implanted

G7 PPS Acetabular component will be implanted

Outcomes

Primary Outcome Measures

Bone Remodelling (DEXA analysis)
DEXA analysis

Secondary Outcome Measures

Clinical (Harris Hip Score)
Harris Hip Score
Clinical (Oxford Hip Score)
Oxford Hip Score

Full Information

First Posted
May 8, 2015
Last Updated
January 12, 2022
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT02447653
Brief Title
Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxyapatite Coating
Arm Type
Experimental
Arm Description
G7 HA Acetabular component will be implanted
Arm Title
Plasma Porous Spray
Arm Type
Active Comparator
Arm Description
G7 PPS Acetabular component will be implanted
Intervention Type
Device
Intervention Name(s)
G7 HA Acetabular Component
Intervention Description
G7 HA Acetabular Component
Intervention Type
Device
Intervention Name(s)
G7 PPS Acetabular Component
Intervention Description
G7 PPS Acetabular Component
Primary Outcome Measure Information:
Title
Bone Remodelling (DEXA analysis)
Description
DEXA analysis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical (Harris Hip Score)
Description
Harris Hip Score
Time Frame
24 months
Title
Clinical (Oxford Hip Score)
Description
Oxford Hip Score
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liu
Organizational Affiliation
Gold Coast Centre for Bone and Joint Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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