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

DePuy Orthopaedics245 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Avascular Necrosis Acute Fracture

Interventions

non-coated femoral hip stemDEVICE

total hip replacement

coated femoral hip stemDEVICE

total hip replacement

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

DePuy Orthopaedics

Warsaw, Indiana, United States

Outcomes

Primary Outcomes

Harris Hip Score (HHS)

The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.

Time frame: Preoperative, 6, 12, 24, 36, 48, and 60 months

Secondary Outcomes

Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.

Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency \> 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p \< .10, Spot-Welds (Lateral View) p \< .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View)

Time frame: Postoperative, 6, 12, 24, 36, 48 and 60 months

Data from ClinicalTrials.gov

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