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The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Experimental | hip resurfacing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cormet Hip Resurfacing | Device | Cormet Hip Resurfacing implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 | Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points. | Month 24+ |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20006 | United States | ||
| Florida Orthopaedic Institute |
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Between 24 Apr 2008 and 21 Dec 2011, 147 participants were enrolled in 6 study hospitals, with 160 Cormet resurfacing implants in 134 unilateral and 13 bilateral procedures.
| ID | Title | Description |
|---|---|---|
| FG000 | Post-PMA Study | Implanted with Cormet Hip Resurfacing System after pre-market approval. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cormet Hip Resurfacing Post-PMA Group | Cormet Resurfacing Hip System implanted after pre-market approval |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 | Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points. | Posted | Number | Implants | Month 24+ | Implants | Implants |
|
|
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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 | Cormet Hip Resurfacing Post-PMA Group | 0 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart valve replacement | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucinda Gerber | Corin USA Limited | (772) 321 2478 | lucinda.gerber@coringroup.com |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Month 24+ |
| Survival Rate Using Kaplan-Meier Survival Curves | Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24 | Month 24+ |
| Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events | Month 24+ |
| The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis | Month 24+ |
| Tampa |
| Florida |
| 33637 |
| United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Lattimore Orthopaedics P.C. | Rochester | New York | 14620 | United States |
| Willamette Orthopedic Group LLC | Salem | Oregon | 97301 | United States |
| Memorial Bone and Joint Clinic | Houston | Texas | 77043 | United States |
| Implants |
|
| years |
| Implants |
|
| Sex: Female, Male | Count of Units | Implants | Implants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Implants |
|
|
| Secondary | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9) | Posted | Count of Units | Implants | No | Month 24+ | Implants | Implants |
|
|
|
| Secondary | Survival Rate Using Kaplan-Meier Survival Curves | Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24 | Posted | Count of Units | Implants | Month 24+ | Implants | Implants |
|
|
|
| Secondary | Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events | Posted | Count of Units | Implants | Month 24+ | Implants | Implants |
|
|
|
| Secondary | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis | Posted | Count of Units | Implants | Month 24+ | Implants | Implants |
|
|
|
| 33 |
| 147 |
| 20 |
| 147 |
| Myocardial infarction | Cardiac disorders |
|
| Inguinal hernia | Gastrointestinal disorders |
|
| Cellulitis | Infections and infestations |
|
| Deep joint infection | Infections and infestations |
|
| Meniscus tear | Injury, poisoning and procedural complications |
|
| Hip pseudotumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Acetabular loosening | Surgical and medical procedures |
|
| Contralateral hip resurfacing | Surgical and medical procedures |
|
| Contralateral revision THR | Surgical and medical procedures |
|
| Contralateral revision TKR | Surgical and medical procedures |
|
| Contralateral THR | Surgical and medical procedures |
|
| Contralateral TKA | Surgical and medical procedures |
|
| Femoral loosening | Surgical and medical procedures |
|
| Femoral neck fracture | Surgical and medical procedures |
|
| Hip dislocation | Surgical and medical procedures |
|
| Fibula fracture | Injury, poisoning and procedural complications |
|
| Hamstring detachment | Injury, poisoning and procedural complications |
|
| Hip pain (operative side) | Injury, poisoning and procedural complications |
|
| Meniscus tear | Injury, poisoning and procedural complications |
|
| Contralateral hip pain | Musculoskeletal and connective tissue disorders |
|
| Contralateral OA | Musculoskeletal and connective tissue disorders |
|
| Groin pain | Musculoskeletal and connective tissue disorders |
|
| Hip pain (operative side) | Musculoskeletal and connective tissue disorders |
|
| Iliopsoas tendonitis | Musculoskeletal and connective tissue disorders |
|
| IT band friction syndrome | Musculoskeletal and connective tissue disorders |
|
| Knee pain | Musculoskeletal and connective tissue disorders |
|
| L5-S1 spondylolisthesis | Musculoskeletal and connective tissue disorders |
|
| Hip dislocation | Surgical and medical procedures |
|
| DVT | Vascular disorders |
|
The sponsor will review publications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. If the sponsor determines the publication contains patentable subject matter the embargo can be extended up to 120 days from the time submitted to the sponsor for review. The PI shall agree to accept the sponsor's reasonable comments and suggestions with respect to publications.
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Total HHS Poor (<70) |
|
| Total HHS missing |
|
| Pain HHS None |
|
| Pain HHS Slight |
|
| Pain HHS Mild |
|
| Pain HHS Moderate |
|
| Pain HHS Marked |
|
| Pain HHS Totally Disabled |
|
| Pain HHS missing |
|
| Function HHS Normal (40-47) |
|
| Function HHS Mild Dysfunction (30=<39) |
|
| Function HHS Moderate Dysfunction (20=<29) |
|
| Function HHS Severe Dysfunction (10=<19) |
|
| Function HHS Disabled (0=<9) |
|
| Title | Measurements |
|---|---|
|
| Radiolucency Femoral Component - Superior |
|
| Radiolucency Femoral Component - Tip |
|
| Radiolucency Femoral Component - Inferior |
|
| Superior/Inferior Cup Migration > 4mm |
|
| Medial/Lateral Cup Migration > 4mm |
|
| Varus/Valgus Cup Tilt > 4 degrees |
|
| Stem subsidence of > 4mm and stem tilt of > 4° |
|
| Anteversion of the Head ≥ 5mm |
|
| Retroversion of the Head ≥ 5 mm |
|
| Hypertrophy in Any Zone |
|
| Resorption in Any Zone |
|
| Lysis in Any Zone |
|
| Osteolysis |
|