Back to resultsClinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement (SPD)
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-coated femoral hip stem
coated femoral hip stem
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total Hip Replacement
Eligibility Criteria
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
Sites / Locations
- DePuy Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
DuoFix HA
Porocoat porous coated
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306917
Brief Title
Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
Acronym
SPD
Official Title
A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to limited enrollment and follow up.
Study Start Date
November 1, 2002 (Actual)
Primary Completion Date
January 29, 2009 (Actual)
Study Completion Date
January 29, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis, Acute Fracture
Keywords
Total Hip Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
DuoFix HA
Arm Title
2
Arm Type
Active Comparator
Arm Description
Porocoat porous coated
Intervention Type
Device
Intervention Name(s)
non-coated femoral hip stem
Other Intervention Name(s)
Summit DuoFix HA hip stem
Intervention Description
total hip replacement
Intervention Type
Device
Intervention Name(s)
coated femoral hip stem
Other Intervention Name(s)
Summit Porocoated porous coated hip stem.
Intervention Description
total hip replacement
Primary Outcome Measure Information:
Title
Harris Hip Score (HHS)
Description
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 Outcome Measure Information:
Title
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Fisher, MD
Organizational Affiliation
Orthopaedics Indianapolis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J W Mesko, MD
Organizational Affiliation
Michigan Orthopaedics Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Perona, MD
Organizational Affiliation
St Margaret's Hospital Family Orthopaedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan B Lowe, MD
Organizational Affiliation
Orthopaedic Specialists of the Carolinas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald L Pomeroy, MD
Organizational Affiliation
Pomeroy & Reddy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nithin Reddy, MD
Organizational Affiliation
Pomeroy & Reddy
Official's Role
Principal Investigator
Facility Information:
Facility Name
DePuy Orthopaedics
City
Warsaw
State/Province
Indiana
ZIP/Postal Code
46581
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
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