Complications; Arthroplasty, Osteoarthritis, Hip
Conditions
Brief summary
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
Interventions
DEVICERevelation Hip Stem (Revelation)
Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.
Sponsors
DJO Incorporated
Encore Medical, L.P.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002. * Surgery must have been a primary total hip replacement * Subject must have received only one primary hip replacement per hospitalization * Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis * Subject must be willing and able to sign the informed consent document
Exclusion criteria
* Subject must not have had any previous hip implants (hemi or total joint) * Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease) * Subject is a prisoner * Subject is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of the Device | 10 year | The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario McMaster Arthritis Index (WOMAC) | 10 year | Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. |
| Harris Hip Score | 10 year | A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result. |
Countries
United States
Participant flow
Recruitment details
The site had a list of patients to call based on previous enrollment into an IDE study from back in 1998. There was not additional recruitment required.
Pre-assignment details
Assignment was based on subjects signing the consent form. They were either in the study or not.
Participants by arm
| Arm | Count |
|---|---|
| Revelation Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Revelation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 61.6 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Survivorship of the Device
The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.
Time frame: 10 year
Population: Subjects who signed the consent form and completed the study paperwork.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Revelation | Survivorship of the Device | 8 participants |
Secondary
Harris Hip Score
A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.
Time frame: 10 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Revelation | Harris Hip Score | 82.4 units on a scale | Standard Deviation 15.4 |
Secondary
Western Ontario McMaster Arthritis Index (WOMAC)
Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Time frame: 10 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Revelation | Western Ontario McMaster Arthritis Index (WOMAC) | 17.4 units on a scale | Standard Deviation 4.6 |