Not provided
Not provided
Not provided
Not provided
Terminated due to limited enrollment and follow up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | DuoFix HA |
|
| 2 | Active Comparator | Porocoat porous coated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-coated femoral hip stem | Device | total hip replacement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction. | Preoperative, 6, 12, 24, 36, 48, and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency > 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p < .10, Spot-Welds (Lateral View) p < .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David A Fisher, MD | Orthopaedics Indianapolis | Principal Investigator |
| J W Mesko, MD | Michigan Orthopaedics Center | Principal Investigator |
| Paul Perona, MD | St Margaret's Hospital Family Orthopaedics | Principal Investigator |
| Stephan B Lowe, MD | Orthopaedic Specialists of the Carolinas | Principal Investigator |
| Donald L Pomeroy, MD | Pomeroy & Reddy | Principal Investigator |
| Nithin Reddy, MD | Pomeroy & Reddy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DePuy Orthopaedics | Warsaw | Indiana | 46581 | United States |
Immediately before surgery, the implant type was determined according to the randomization schedule. Enrolled subjects may have been excluded from the trial before assignment to the study arm based upon results of pre-operative clinical evaluations and radiographs that would exclude a subject based on exclusion criteria in the study protocol.
Recruitment began in September 2002 and ended June 2006. Study subjects were recruited and enrolled in medical clinics by orthopaedic surgeons at eight investigational sites. Each site could enroll a maximum of 50 subjects. Recruitment was based on the inclusion and exclusion criteria as indicated in the study protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DuoFix HA | The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| coated femoral hip stem | Device | total hip replacement |
|
|
| Postoperative, 6, 12, 24, 36, 48 and 60 months |
| FG001 | Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| Postoperative to 6 Month Follow up |
|
| 12 Month Follow |
|
| 24 Month Follow up |
|
| 36 Month Follow up |
|
| 48 Month Follow up |
|
| 60 Month Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DuoFix HA | The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| BG001 | Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency > 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p < .10, Spot-Welds (Lateral View) p < .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View) | Posted | Number | Percentage of Participants Analyzed | Postoperative, 6, 12, 24, 36, 48 and 60 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Harris Hip Score (HHS) | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction. | Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores. | Posted | Mean | Standard Deviation | Units on a scale | Preoperative, 6, 12, 24, 36, 48, and 60 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DuoFix HA | The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. | 3 | 121 | 6 | 121 | ||
| EG001 | Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. | 4 | 124 | 7 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular Arrhythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Infection: Deep | Infections and infestations | Non-systematic Assessment |
| ||
| Infection: Superficial | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Liner failure: dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Loss Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
The protocol called for 400 subjects to be followed for 5 years, but due to slow enrollment the study closed early. 245 subjects were enrolled & study endpoint was modified to 2 years. Enrollment closed on June 30, 2006; study closed on Jan 29, 2009.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry Sisson | DePuy Orthopaedics, Inc | 574-372-7156 | BSisson@its.jnj.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Radiolucency > 2 mm in any zone |
|
| Complete Circumferential Radiolucencies |
|
| Spot-Welds (AP View) p < .10 |
|
| Spot-Welds (Lateral View) p < .10 |
|
| Cortical Hypertrophy (AP View) |
|
| Cortical Hypertrophy (Lateral View) |
|
| OG001 | Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
|
|