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

Not Applicable

Terminated

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

• Registration Number: NCT00306917
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2002-11-01
• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-27
• Primary Completion: 2009-01-29
• Study Completion: 2009-01-29
• Results First Submitted: 2010-01-29
• Results First Submitted QC: 2010-02-23
• Results First Posted: 2010-03-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS)	Preoperative, 6, 12, 24, 36, 48, and 60 months	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.

Secondary Outcome Measures

Name	Time	Method
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.	Postoperative, 6, 12, 24, 36, 48 and 60 months	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)

Trial Locations

Locations (1)

DePuy Orthopaedics; 🇺🇸 Warsaw, Indiana, United States