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Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty (PeriBRUSBRAC)

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Hip replacement

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Periprosthetic bone remodeling, Stress shielding, Short femoral stem, Porous Titanium Construct, Polyethylene wear

Eligibility Criteria

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

Inclusion Criteria:

Age 40-70 years old
Primary osteoarthritis of the hip
Type A or B femur according to Dorr10
Femoral anatomy allowing implantation of both femoral stems
Willingness and ability to follow study-protocol -

Exclusion Criteria:

Inflammatory arthritis
Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components
Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
Ongoing oestrogen treatment
Type C femur according to Dorr
Not suited for the study for other reason (surgeons preference)

Sites / Locations

Orthopaedic Department, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hip Arthroplasty, ultra-short stem, conventional cup

Hip Arthroplasty, conventional stem, trabecular-titanium cup

Arm Description

Hip replacement with a hydroxy-apatite covered ultra-short uncemented femoral stem and a conventional uncemented acetabular cup with hydroxy-apatite covered porous coating and a moderately cross-linked polyethylene cup liner

Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner

Outcomes

Primary Outcome Measures

Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)

Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)

Secondary Outcome Measures

Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)

Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)

Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)

Full Information

NCT ID

NCT01319227

First Posted

March 18, 2011

Last Updated

August 29, 2016

Sponsor

Danderyd Hospital

Collaborators

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01319227

Brief Title

Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

Acronym

PeriBRUSBRAC

Official Title

Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Danderyd Hospital

Collaborators

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation. Hypothesis: A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem. An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.

Detailed Description

Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study. Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.

6. Conditions and Keywords

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

Osteoarthritis

Keywords

Periprosthetic bone remodeling, Stress shielding, Short femoral stem, Porous Titanium Construct, Polyethylene wear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hip Arthroplasty, ultra-short stem, conventional cup

Arm Type

Experimental

Arm Description

Arm Title

Hip Arthroplasty, conventional stem, trabecular-titanium cup

Arm Type

Experimental

Arm Description

Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner

Intervention Type

Procedure

Intervention Name(s)

Hip replacement

Other Intervention Name(s)

Ultra-short hydroxyapatite-coated Proxima stem and hydroxyapatite covered porous coated Pinnacle cup from DePuy, Johnson&Johnson., Tapered, proximally porous and hydroxyapatite-coated, Bimetric stem and a Regenerex cup with trabecular-Titanium-backside from Biomet.

Intervention Description

Hip arthroplasty with uncemented components

Primary Outcome Measure Information:

Title

Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)

Time Frame

bone mineral density (BMD) measured postoperatively at 2 years.

Title

Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)

Time Frame

bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcome Measure Information:

Title

Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)

Time Frame

at 2 years

Title

Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)

Time Frame

at 2 years

Title

Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)

Time Frame

at 6 and 10 years

Title

Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)

Time Frame

at 6 and 10 years.

Other Pre-specified Outcome Measures:

Title

Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components

Description

Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 40-70 years old Primary osteoarthritis of the hip Type A or B femur according to Dorr10 Femoral anatomy allowing implantation of both femoral stems Willingness and ability to follow study-protocol - Exclusion Criteria: Inflammatory arthritis Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery Ongoing oestrogen treatment Type C femur according to Dorr Not suited for the study for other reason (surgeons preference)

Facility Information:

Facility Name

Orthopaedic Department, Danderyd Hospital

City

Stockholm

ZIP/Postal Code

18288

Country

Sweden

12. IPD Sharing Statement

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Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

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