Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

NCT ID: NCT01319227

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2023-08-31

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:

1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.

2. 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.

Conditions

Osteoarthritis

Study Design

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

Study Groups

Hip Arthroplasty, ultra-short stem, conventional cup

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

Group Type: EXPERIMENTAL

Hip replacement

Intervention Type: PROCEDURE

Hip arthroplasty with uncemented components

Hip Arthroplasty, conventional stem, trabecular-titanium cup

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

Group Type: EXPERIMENTAL

Hip replacement

Intervention Type: PROCEDURE

Hip arthroplasty with uncemented components

Interventions

Hip replacement

Hip arthroplasty with uncemented components

Intervention Type: PROCEDURE

Other Intervention Names

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.

Eligibility Criteria

Inclusion Criteria

1. Age 40-70 years old

2. Primary osteoarthritis of the hip

3. Type A or B femur according to Dorr10

4. Femoral anatomy allowing implantation of both femoral stems

5. Willingness and ability to follow study-protocol -

Exclusion Criteria

1. Inflammatory arthritis

2. Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components

3. Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery

4. Ongoing oestrogen treatment

5. Type C femur according to Dorr

6. Not suited for the study for other reason (surgeons preference)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olof Skoldenberg

Consultant Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthopaedic Department, Danderyd Hospital

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

PeriBRUSBRAC

Identifier Type: -

Identifier Source: org_study_id