NCT00306917

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 10, 2010

Completed
Last Updated

July 19, 2022

Status Verified

June 1, 2022

Enrollment Period

6.2 years

First QC Date

March 23, 2006

Results QC Date

January 29, 2010

Last Update Submit

June 24, 2022

Conditions

OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisAvascular NecrosisAcute Fracture

Keywords

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

DuoFix HA

Device: non-coated femoral hip stem

2

ACTIVE COMPARATOR

Porocoat porous coated

Device: coated femoral hip stem

Interventions

non-coated femoral hip stemDEVICE

total hip replacement

Also known as: Summit DuoFix HA hip stem
1
coated femoral hip stemDEVICE

total hip replacement

Also known as: Summit Porocoated porous coated hip stem.
2

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip replacement
  • Patient age less than or equal to 75
  • Sufficient bone stock to support prosthesis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DePuy Orthopaedics

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

The protocol called for 400 subjects to be followed for 5 years, but due to slow enrollment the study closed early. 245 subjects were enrolled \& study endpoint was modified to 2 years. Enrollment closed on June 30, 2006; study closed on Jan 29, 2009.

Results Point of Contact

Title
Barry Sisson
Organization
DePuy Orthopaedics, Inc
BSisson@its.jnj.com
574-372-7156

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

November 1, 2002

Primary Completion

January 29, 2009

Study Completion

January 29, 2009

Last Updated

July 19, 2022

Results First Posted

March 10, 2010

Record last verified: 2022-06

Locations

US(1)