NCT00962013

Brief Summary

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

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

January 1, 2004

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

7.9 years

First QC Date

August 13, 2009

Results QC Date

April 4, 2014

Last Update Submit

February 10, 2017

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (2)

  • Stem Survivorship (%)

    Failure is defined by stem revision for any cause.

    5 years

  • Femoral Stem Fracture

    5 years

Secondary Outcomes (4)

  • Radiographic Stability

    5 years

  • Harris Hip Score

    pre-op and 5 years

  • SF-36 Health Status Survey: Role - Physical

    pre-op, 2 year and 5 year

  • Post-surgery Femoral Crack/Fracture and Subsidence Rate

    Post-op to 5 years

Study Arms (1)

Restoration® Modular

OTHER

All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.

Device: Restoration® Modular Revision Hip System

Interventions

Restoration® Modular Revision Hip SystemDEVICE

Restoration® Modular Revision System

Restoration® Modular

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for cementless revision of a failed femoral prosthesis.
  • Patients willing to sign the informed consent.
  • Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
  • Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

You may not qualify if:

  • Patients with ongoing infection.
  • Patients who are severely immunocompromised.
  • Patients who are prisoners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

Iowa Orthopaedic Center

Des Moines, Iowa, 50314, United States

Location

Kansas Joint and Spine Institute

Wichita, Kansas, 67226, United States

Location

Jewish Hospital Center for Advanced Medicine

Louisville, Kentucky, 40202, United States

Location

New West Sports Medicine and Orthopaedic Surgery

Kearney, Nebraska, 68847, United States

Location

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Beth Israel Medical Center

New York, New York, 10021, United States

Location

Crystal Clinic

Akron, Ohio, 44333, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Orthopedic Associates of Corpus Christi

Corpus Christi, Texas, 78411, United States

Location

Scott and White Hospital

Temple, Texas, 76508, United States

Location

Providence Orthopaedic Specialities

Spokane, Washington, 99204, United States

Location

Results Point of Contact

Title
Director of Clinical Research
Organization
Stryker Orthopaedics
Ellen.Axelson@stryker.com
201-831-5401

Study Officials

  • Steven Barnett, MD

    Orthopaedic Specialty Institute

    PRINCIPAL INVESTIGATOR

  • Michael W Britt, MD

    Orthopaedic Associates of Corpus Christi

    PRINCIPAL INVESTIGATOR

  • Kenneth A Greene, MD

    Crystal Clinic

    PRINCIPAL INVESTIGATOR

  • Steven F Harwin, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

  • D. Christopher Hikes, MD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

  • Kirby Hitt, MD

    Scott and White Hospital

    PRINCIPAL INVESTIGATOR

  • William Hozack, md

    Rothman Institute

    PRINCIPAL INVESTIGATOR

  • Frederick Jaffe, MD

    Hospital for Joint Diseases

    PRINCIPAL INVESTIGATOR

  • Timothy P Lovell, MD

    Providence Orthopaedic Specialties

    PRINCIPAL INVESTIGATOR

  • Mark R Matthes, MD

    Iowa Orthopaedic Center

    PRINCIPAL INVESTIGATOR

  • Arthur Malkani, MD

    Jewish Hospital Center for Advanced Medicine

    PRINCIPAL INVESTIGATOR

  • John Schurman, MD

    Kansas Joint and Spine Institute

    PRINCIPAL INVESTIGATOR

  • John Wright, MD

    New West Sports Medicine and Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 19, 2009

Study Start

January 1, 2004

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 29, 2017

Results First Posted

August 15, 2014

Record last verified: 2017-02

Locations

US(13)