Retrospective Study of the Linear™ Hip

This study has been terminated.
(Enrollment and data collection insufficient to continue study.)
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764959
First received: September 30, 2008
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip System in a group of 200 patients for whom data has already been collected.


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Femoral Fracture
Correction of a Functional Deformity
Avascular Necrosis
Device: Encore Linear™ Hip System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Market Study of the Linear™ Hip System

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • The use and efficacy of the Encore Linear™ Hip System [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Linear Hip
Encore Linear Hip System
Device: Encore Linear™ Hip System
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who meet the indications for use of the Linear Hip device AND who meet the inclusion/exclusion criteria

Criteria

Inclusion Criteria:

  • Have hip joint disease related to one or more of the following

    • osteoarthritis
    • rheumatoid arthritis
    • femoral fracture
    • correction of a functional deformity
    • avascular necrosis of the natural femoral head
  • Skeletal maturity
  • Patient is likely to be available for evaluation for the duration of the study
  • Able and willing to sign the informed consent and follow study procedures
  • Patient is not pregnant
  • No infection present
  • No known materials sensitivity
  • Patient is over 18 years of age

Exclusion Criteria:

  • Skeletal immaturity
  • Infection or sepsis
  • Insufficient bone quality that may affect the stability of the implant
  • Muscular, neurologic or vascular deficiencies which compromise the affected extremity
  • Alcoholism or other addictions
  • Prisoners
  • High levels of physical activity
  • Patient is pregnant
  • Loss of ligamentous structures
  • Materials sensitivity
  • Patient is under 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764959

Locations
United States, Florida
Hussamy Orthopedics
Vero Beach, Florida, United States, 32960
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: Omar Hussamy, M.D. Hussamy Orthopedics
  More Information

Additional Information:
No publications provided

Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764959     History of Changes
Other Study ID Numbers: PS - 800
Study First Received: September 30, 2008
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis
Femoral Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 16, 2014