Acute Fracture, Avascular Necrosis, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Replacement
Brief summary
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
Detailed description
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.
Interventions
DEVICEnon-coated femoral hip stem
total hip replacement
DEVICEcoated femoral hip stem
total hip replacement
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Primary total hip replacement * Patient age less than or equal to 75 * Sufficient bone stock to support prosthesis
Exclusion criteria
* Previous hip replacement * Significant angular/bony deformity * Active joint sepsis * Metal allergy * Renal transplant * Psychosocial disease * Neurological disease/musculoskeletal disease that may affect weight-bearing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | Preoperative, 6, 12, 24, 36, 48, and 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Postoperative, 6, 12, 24, 36, 48 and 60 months | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 121 |
| 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. | 124 |
| Total | 245 |
Baseline characteristics
| Characteristic | DuoFix HA | Porocoat Porous Coated | Total |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 8.2 | 63.2 years STANDARD_DEVIATION 9.2 | 63.8 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States United States | 121 Participants | 124 Participants | 245 Participants |
| Sex: Female, Male Female | 67 Participants | 64 Participants | 131 Participants |
| Sex: Female, Male Male | 54 Participants | 60 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 121 | 7 / 124 |
| serious Total, serious adverse events | 3 / 121 | 4 / 124 |
Outcome results
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.
Time frame: Preoperative, 6, 12, 24, 36, 48, and 60 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DuoFix HA | Harris Hip Score (HHS) | 12 Month HHS | 92.8 Units on a scale | Standard Deviation 7.9 |
| DuoFix HA | Harris Hip Score (HHS) | 36 Month HHS | 94.0 Units on a scale | Standard Deviation 8.5 |
| DuoFix HA | Harris Hip Score (HHS) | Postoperative to 6 Month HHS | 90.2 Units on a scale | Standard Deviation 10.3 |
| DuoFix HA | Harris Hip Score (HHS) | 48 Month HHS | 91.8 Units on a scale | Standard Deviation 12.2 |
| DuoFix HA | Harris Hip Score (HHS) | 24 Month HHS | 93.3 Units on a scale | Standard Deviation 7.8 |
| DuoFix HA | Harris Hip Score (HHS) | 60 Month HHS | 93.8 Units on a scale | Standard Deviation 7.9 |
| DuoFix HA | Harris Hip Score (HHS) | Preoperative HHS | 49.9 Units on a scale | Standard Deviation 13.4 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | 60 Month HHS | 93.6 Units on a scale | Standard Deviation 7.8 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | Preoperative HHS | 51.2 Units on a scale | Standard Deviation 14 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | Postoperative to 6 Month HHS | 91.6 Units on a scale | Standard Deviation 8.3 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | 12 Month HHS | 92.3 Units on a scale | Standard Deviation 11.6 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | 24 Month HHS | 93.5 Units on a scale | Standard Deviation 9.7 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | 36 Month HHS | 93.8 Units on a scale | Standard Deviation 9.4 |
| Porocoat Porous Coated | Harris Hip Score (HHS) | 48 Month HHS | 95.5 Units on a scale | Standard Deviation 10.5 |
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)
Time frame: Postoperative, 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Subsidence (10 mm) | 1 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Osseointegration | 82 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Radiolucency > 2 mm in any zone | 0 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Complete Circumferential Radiolucencies | 0 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Spot-Welds (AP View) p < .10 | 23 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Spot-Welds (Lateral View) p < .10 | 8 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Cortical Hypertrophy (AP View) | 12 Percentage of Participants Analyzed |
| DuoFix HA | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Cortical Hypertrophy (Lateral View) | 3 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Cortical Hypertrophy (Lateral View) | 4 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Subsidence (10 mm) | 0 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Spot-Welds (AP View) p < .10 | 14 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Osseointegration | 80 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Cortical Hypertrophy (AP View) | 12 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Radiolucency > 2 mm in any zone | 0 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Spot-Welds (Lateral View) p < .10 | 3 Percentage of Participants Analyzed |
| Porocoat Porous Coated | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. | Complete Circumferential Radiolucencies | 0 Percentage of Participants Analyzed |