Retrospective Study of the Linear™ Hip
This study has been terminated.
(Enrollment and data collection insufficient to continue study.)
Sponsor:
Encore Medical, L.P.
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
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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 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:
|
Congenital Abnormalities Arthritis Arthritis, Rheumatoid Femoral Fractures Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Fractures, Bone Wounds and Injuries Leg Injuries Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on June 18, 2013