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

Study Overview
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Brief Summary
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Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Detailed Description
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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.

Official Title
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A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis, Acute Fracture

Intervention / Treatment
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* Device: non-coated femoral hip stem
* Device: coated femoral hip stem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>DuoFix HA | Device: non-coated femoral hip stem<br>* total hip replacement<br>* Other names: Summit DuoFix HA hip stem;|
| Active Comparator: 2<br>Porocoat porous coated | Device: coated femoral hip stem<br>* total hip replacement<br>* Other names: Summit Porocoated porous coated hip stem.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Preoperative, 6, 12, 24, 36, 48, and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Postoperative, 6, 12, 24, 36, 48 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Replacement