Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Sahlgrenska University Hospital

Status: Unknown

Conditions: Arthroplasty Complications

Treatments: Device: Ceramic-on-ceramic uncemented hip arthroplasty; Device: Metal-on-polyethylene uncemented total hip arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03692364

Protesteam_ceram

Details and patient eligibility

About

Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

Enrollment: 104 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary osteoarthritis
• secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion criteria

• inflammatory arthritis
• hip joint infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

104 participants in 2 patient groups

Metal-on-conventional polyethylene

Active Comparator group

Description:

Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US).

Treatment:

Device: Metal-on-polyethylene uncemented total hip arthroplasty

Ceramic-on-ceramic

Experimental group

Description:

Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany).

Treatment:

Device: Ceramic-on-ceramic uncemented hip arthroplasty