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Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty

Primary Purpose

Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
THA with G7 PPS coted acetabular component
THA with G7 OsseoTi coted acetabular component
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.

    • Participants must be 18-75 years of age.
    • Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
    • Participants must be able to give informed consent and be cognitively intact.
    • Participants must be expected to be able to complete all postoperative controls.
    • Participants must not have severe comorbidities, ASA-score ≤ 3.

Exclusion Criteria:

  • Terminal illness.
  • Rheumatoid arthritis.
  • Previous fracture of the hip.
  • Osteonecrosis of the hip.
  • Previous infection of the hip.
  • Severe bony deformity warranting the use of non-standard implants.
  • Metastasis in the periarticular bone or proximal femur.
  • Female patients that are pregnant or planning pregnancy during follow-up period
  • If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
  • Documented osteoporosis with patient in active medical treatment.
  • Comorbidity with altered pain perception (e.g. DM with neuropathy).
  • Participants that develop deep infection in the follow-up period are excluded from the project.

Sites / Locations

  • Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
  • Sahlgrenska University Hospital, Department of Orthopedics,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

OsseoTi™ G7 large

OsseoTi™ G7 32

conventional PPS coated G7 large

conventional PPS coated G7 32

Arm Description

OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)

OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head

conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)

conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head

Outcomes

Primary Outcome Measures

RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2014
Last Updated
February 8, 2021
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02316704
Brief Title
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty
Official Title
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.

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
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OsseoTi™ G7 large
Arm Type
Active Comparator
Arm Description
OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)
Arm Title
OsseoTi™ G7 32
Arm Type
Active Comparator
Arm Description
OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head
Arm Title
conventional PPS coated G7 large
Arm Type
Active Comparator
Arm Description
conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)
Arm Title
conventional PPS coated G7 32
Arm Type
Active Comparator
Arm Description
conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head
Intervention Type
Device
Intervention Name(s)
THA with G7 PPS coted acetabular component
Intervention Type
Device
Intervention Name(s)
THA with G7 OsseoTi coted acetabular component
Primary Outcome Measure Information:
Title
RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
Description
Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty. Participants must be 18-75 years of age. Participants must be able to speak and understand Danish (or depending on country where patient is enrolled). Participants must be able to give informed consent and be cognitively intact. Participants must be expected to be able to complete all postoperative controls. Participants must not have severe comorbidities, ASA-score ≤ 3. Exclusion Criteria: Terminal illness. Rheumatoid arthritis. Previous fracture of the hip. Osteonecrosis of the hip. Previous infection of the hip. Severe bony deformity warranting the use of non-standard implants. Metastasis in the periarticular bone or proximal femur. Female patients that are pregnant or planning pregnancy during follow-up period If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation. Documented osteoporosis with patient in active medical treatment. Comorbidity with altered pain perception (e.g. DM with neuropathy). Participants that develop deep infection in the follow-up period are excluded from the project.
Facility Information:
Facility Name
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Sahlgrenska University Hospital, Department of Orthopedics,
City
Gothenburg
ZIP/Postal Code
SW-431 80
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty

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