Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement (SPD)

DePuy Synthes

Status: Terminated

Conditions: Osteoarthritis; Acute Fracture; Avascular Necrosis; Post-traumatic Arthritis; Rheumatoid Arthritis

Treatments: Device: non-coated femoral hip stem; Device: coated femoral hip stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306917

SPD

Details and patient eligibility

About

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Full description

Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

Enrollment: 245 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary total hip replacement
• Patient age less than or equal to 75
• Sufficient bone stock to support prosthesis

Exclusion criteria

• Previous hip replacement
• Significant angular/bony deformity
• Active joint sepsis
• Metal allergy
• Renal transplant
• Psychosocial disease
• Neurological disease/musculoskeletal disease that may affect weight-bearing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

1

Active Comparator group

Description:

DuoFix HA

Treatment:

Device: non-coated femoral hip stem

2

Active Comparator group

Description:

Porocoat porous coated

Treatment:

Device: coated femoral hip stem