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
• Interventions: Device: coated femoral hip stem; Device: non-coated femoral hip stem

• 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

Arm && Interventions

Group	Intervention	Description
2	coated femoral hip stem	Porocoat porous coated
1	non-coated femoral hip stem	DuoFix HA

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