Trial Outcomes & Findings for Encore Revelation Hip Stem (NCT NCT01514318)
NCT ID: NCT01514318
Last Updated: 2012-11-30
Results Overview
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.
COMPLETED
8 participants
10 year
2012-11-30
Participant Flow
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.
Assignment was based on subjects signing the consent form. They were either in the study or not.
Participant milestones
| Measure |
Revelation
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Encore Revelation Hip Stem
Baseline characteristics by cohort
| Measure |
Revelation
n=8 Participants
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
61.6 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearPopulation: Subjects who signed the consent form and completed the study paperwork.
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.
Outcome measures
| Measure |
Revelation
n=8 Participants
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
|
|---|---|
|
Survivorship of the Device
|
8 participants
|
SECONDARY outcome
Timeframe: 10 yearStandardized 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.
Outcome measures
| Measure |
Revelation
n=8 Participants
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
|
|---|---|
|
Western Ontario McMaster Arthritis Index (WOMAC)
|
17.4 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 10 yearA 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.
Outcome measures
| Measure |
Revelation
n=8 Participants
Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
|
|---|---|
|
Harris Hip Score
|
82.4 units on a scale
Standard Deviation 15.4
|
Adverse Events
Revelation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60