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Terminated due to lagging follow-up
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The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnifit HA Hip Stem | Other | Participants underwent total hip replacement surgery using the Omnifit HA Hip Stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnifit HA Hip Stem | Device | Total Hip Replacement with Omnifit HA Hip Stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. | 25 Years Post-Operatively |
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Inclusion Criteria:
For use as a universal hip replacement:
For use as a total hip replacement:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Capello, MD | Indiana University Medical Center | Study Chair |
| William Jaffe, MD | Hospital for Joint Disease/ Orthopaedic Institute | Principal Investigator |
| Rudolph Geesink, MD | Trialbureau Orthopedics | Principal Investigator |
| James D'Antonio, MD | Sewickley Valley Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States | ||
| Hospital for Joint Disease/ Orthopaedic Institute |
226 participants = 262 hips
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| ID | Title | Description |
|---|---|---|
| FG000 | Omnifit HA Hip Stem | Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omnifit HA Hip Stem | Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For bilateral total hip replacement participants, the age at the time of the initial hip replacement surgery is used. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. | The study was closed and no subjects reached the 25 year postoperative endpoint. | Posted | 25 Years Post-Operatively |
|
|
22 years
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract & intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, & mid-foot/flat-foot surgeries.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omnifit HA Hip Stem | Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site Cardiac Disorders | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site Musculoskeletal and Connective Tissue Disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | ellen.axelson@stryker.com |
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| New York |
| New York |
| 10128 |
| United States |
| Sewickley Valley Hospital | Moon Township | Pennsylvania | 15108-4305 | United States |
| Trialbureau Orthopedics | Maastricht | 6202 | Netherlands |
| revision/removal |
|
| study termination |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 104 |
| 226 |
| 70 |
| 226 |
| Non-operative Site Gastrointestinal Disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative Site Infections and Infestations | Infections and infestations | Non-systematic Assessment |
|
| Operative Site Infection and Infestation | Infections and infestations | Non-systematic Assessment |
|
| Non-operative Site Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative Site Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-Operative Site Neoplasms Benign,Malignant,and Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non-operative Site Renal and Urinary Disorders | Renal and urinary disorders | Non-systematic Assessment |
|
| Operative Site Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Non-operative Site Vascular Disorders | Vascular disorders | Non-systematic Assessment |
|
| Operative Site Musculoskeletal and Connective Tissue Disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
For 7 years from and after termination date of the agreement, prior to submission for publication of abstracts, manuscripts, presentations or other communications describing the results of any aspect of the Study ("Manuscript"), You and the Institution shall send Stryker Orthopaedics a copy of the Manuscript to be submitted, and allow Stryker Orthopaedics sixty (60) days from the date of receipt to review the Manuscript.