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

June 24, 2022 updated by: DePuy Orthopaedics

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Warsaw, Indiana, United States, 46581
        • DePuy Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
DuoFix HA
Device: non-coated femoral hip stem
total hip replacement
Other Names:
  • Summit DuoFix HA hip stem
Active Comparator: 2
Porocoat porous coated
Device: coated femoral hip stem
total hip replacement
Other Names:
  • Summit Porocoated porous coated hip stem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score (HHS)
Time Frame: 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.
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.
Time Frame: 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)
Postoperative, 6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Investigators

  • Principal Investigator: David A Fisher, MD, Orthopaedics Indianapolis
  • Principal Investigator: J W Mesko, MD, Michigan Orthopaedics Center
  • Principal Investigator: Paul Perona, MD, St Margaret's Hospital Family Orthopaedics
  • Principal Investigator: Stephan B Lowe, MD, Orthopaedic Specialists of the Carolinas
  • Principal Investigator: Donald L Pomeroy, MD, Pomeroy & Reddy
  • Principal Investigator: Nithin Reddy, MD, Pomeroy & Reddy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2002

Primary Completion (Actual)

January 29, 2009

Study Completion (Actual)

January 29, 2009

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on non-coated femoral hip stem

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe