Osteoarthritis, Hip, Traumatic Arthritis of Hip
Conditions
Brief summary
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.
Detailed description
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.
Interventions
DEVICEAnswer® hip stem
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Sponsors
Biomet Orthopedics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Exclusion criteria
* Infection, sepsis, and osteomyelitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 10 Years Post-Operative | The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score Pain | Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year | Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.
Pre-assignment details
The patients were assigned to each group according to the bone cement used with the implant.
Participants by arm
| Arm | Count |
|---|---|
| Answer Stem Utilizing Simplex Cement Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics | 202 |
| Answer Stem Utilizing Palacos Cement Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation. | 200 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 10 Years | Incomplete due to study termination | 107 | 114 |
| 1 Year | Patients did not return for follow-up | 89 | 82 |
| 2 Years | Patients did not return for follow-up | 92 | 87 |
| 4 Years | Patients did not return for follow-up | 91 | 103 |
| 6 Months | Patients did not return for follow-up | 98 | 73 |
| 6 Years | Patients did not return for follow-up | 104 | 109 |
| 8 Years | Patients did not return for follow-up | 105 | 114 |
| Pre-Operative | Patients Did Not Complete Preop Data | 95 | 86 |
Baseline characteristics
| Characteristic | Answer Stem Utilizing Simplex Cement | Answer Stem Utilizing Palacos Cement | Total |
|---|---|---|---|
| Age, Continuous | 73 years | 76 years | 75 years |
| Sex: Female, Male Female | 127 Participants | 142 Participants | 269 Participants |
| Sex: Female, Male Male | 75 Participants | 58 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 202 | 0 / 200 |
| serious Total, serious adverse events | 15 / 202 | 8 / 200 |
Outcome results
Primary
Harris Hip Score
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor.
Time frame: 10 Years Post-Operative
Population: This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Harris Hip Score | Score of 90-100 | — |
| Unknown | Harris Hip Score | Score of 80-89 | — |
| Unknown | Harris Hip Score | Score of 70-79 | — |
| Unknown | Harris Hip Score | Score of <70 | — |
Secondary
Harris Hip Score Pain
Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled.
Time frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Population: This population represents patients that returned for follow-up per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 1 Year Harris Hip Score Pain | 37.89 Mean Hip Pain | Standard Deviation 9.54 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 4 Year Harris Hip Score Pain | 38.38 Mean Hip Pain | Standard Deviation 9.78 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 6 Month Harris Hip Score Pain | 39.78 Mean Hip Pain | Standard Deviation 4.06 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 6 Year Harris Hip Score Pain | 44.00 Mean Hip Pain | Standard Deviation 0 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 2 Year Harris Hip Score Pain | 36.93 Mean Hip Pain | Standard Deviation 9.47 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | 8 Year Harris Hip Score Pain | 37.00 Mean Hip Pain | Standard Deviation 9.9 |
| Answer Stem Utilizing Simplex Cement | Harris Hip Score Pain | Pre-Operative Harris Hip Score Pain | 15.89 Mean Hip Pain | Standard Deviation 7.64 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 8 Year Harris Hip Score Pain | NA Mean Hip Pain | — |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | Pre-Operative Harris Hip Score Pain | 14.74 Mean Hip Pain | Standard Deviation 7.78 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 6 Month Harris Hip Score Pain | 36.25 Mean Hip Pain | Standard Deviation 9.69 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 1 Year Harris Hip Score Pain | 37.76 Mean Hip Pain | Standard Deviation 9.24 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 2 Year Harris Hip Score Pain | 34.59 Mean Hip Pain | Standard Deviation 10.54 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 4 Year Harris Hip Score Pain | 41.27 Mean Hip Pain | Standard Deviation 4.22 |
| Answer Stem Utilizing Palacos Cement | Harris Hip Score Pain | 6 Year Harris Hip Score Pain | 42.00 Mean Hip Pain | Standard Deviation 2.83 |