Osteoarthritis
Conditions
Keywords
Arthritis, Osteoarthritis, Traumatic Arthritis, Degenerative Joint Disease, Avascular Necrosis
Brief summary
This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.
Detailed description
This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients previously enrolled in the IDE study will be evaluated annually through five (5) year follow-up. In addition, all patients enrolled in the original study cohorts as well as the continued access patients will be sent a letter questionnaire annually at the 6-10 year postoperative time point to assess the patient's general well-being and if the study components are still in place
Interventions
DEVICEReflection Ceramic-Ceramic Total Hip Replacement
Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
DEVICEReflection FSO V Total Hip Replacement
Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Criteria Inclusion Criteria: (Patient must meet all of the following characteristics to be enrolled in the study): * Males and females, 21 to 80 years of age, inclusive; * Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously; * The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form; * The patient will be available for follow-up through at least two years postoperative; * The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement); * The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement); * The patient meets none of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of Hip Implant Based on Number of Hips Requiring Revision | Postoperatively through Year 10 | Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only) |
| Survival of Hip Implant Based on Time Until Revision Required | Postoperatively through Year 10 | The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only) |
| Subject Satisfaction Questionnaire | Year 6 through Year 10 postoperatively | A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked Are you satisfied with hip? and subjects responded either yes or no. |
Countries
United States
Participant flow
Pre-assignment details
There were 456 subjects (535 hips) enrolled initially at the beginning of the study. For the Post-Approval Study period (Year 6 through Year 10), 29 subjects (10 from the IP group, 19 from the control group) were excluded from analysis in the Intent-to-Treat (ITT) population and thus not included in the Participant Flow or Outcome Measures for this period.
Participants by arm
| Arm | Count |
|---|---|
| Reflection Ceramic-Ceramic Hip System (IP) Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem. | 308 |
| Reflection FSO V (5 Hole) (Control) Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem. | 148 |
| Total | 456 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial Study (Year 1 up to Year 6) | Lost to Follow-up | 10 | 19 |
| Post-Approval Study (Year 6 to Year 10) | Death | 18 | 7 |
| Post-Approval Study (Year 6 to Year 10) | Lost to Follow-up | 13 | 7 |
| Post-Approval Study (Year 6 to Year 10) | Revision Surgery | 29 | 10 |
| Post-Approval Study (Year 6 to Year 10) | Withdrawal by Subject | 8 | 15 |
| Post-Approval Study (Year 6 to Year 10) | Withdrawn for Site Termination | 44 | 32 |
Baseline characteristics
| Characteristic | Reflection Ceramic-Ceramic Hip System (IP) | Reflection FSO V (5 Hole) (Control) | Total |
|---|---|---|---|
| Age, Customized | 48.7 Years STANDARD_DEVIATION 11.98 | 54.1 Years STANDARD_DEVIATION 12.91 | 50.7 Years STANDARD_DEVIATION 12.59 |
| Body mass index (BMI) | 28.7 kg/m^2 STANDARD_DEVIATION 5.37 | 27.9 kg/m^2 STANDARD_DEVIATION 5.14 | 28.4 kg/m^2 STANDARD_DEVIATION 5.3 |
| Height | 173.0 cm STANDARD_DEVIATION 10.08 | 172.3 cm STANDARD_DEVIATION 9.83 | 172.7 cm STANDARD_DEVIATION 9.98 |
| Other joint involvement No | 92 Participants | 49 Participants | 141 Participants |
| Other joint involvement Yes | 216 Participants | 99 Participants | 315 Participants |
| Physical activity Intense | 5 Participants | 6 Participants | 11 Participants |
| Physical activity Light | 225 Participants | 113 Participants | 338 Participants |
| Physical activity Moderate | 56 Participants | 24 Participants | 80 Participants |
| Physical activity None | 22 Participants | 5 Participants | 27 Participants |
| Previous surgery on affected hip No | 235 Participants | 118 Participants | 353 Participants |
| Previous surgery on affected hip Yes | 73 Participants | 30 Participants | 103 Participants |
| Sex: Female, Male Female | 147 Participants | 71 Participants | 218 Participants |
| Sex: Female, Male Male | 161 Participants | 77 Participants | 238 Participants |
| Weight | 86.4 kg STANDARD_DEVIATION 19.28 | 83.3 kg STANDARD_DEVIATION 18.78 | 85.3 kg STANDARD_DEVIATION 19.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 18 / 308 | 7 / 148 |
| other Total, other adverse events | 0 / 308 | 0 / 148 |
| serious Total, serious adverse events | 18 / 308 | 7 / 148 |
Outcome results
Primary
Subject Satisfaction Questionnaire
A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked Are you satisfied with hip? and subjects responded either yes or no.
Time frame: Year 6 through Year 10 postoperatively
Population: The number analyzed include all enrolled subjects who responded to the questionnaire at each time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 8 - Are you satisfied with hip? | Yes | 177 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 6 - Are you satisfied with hip? | Yes | 107 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 9 - Are you satisfied with hip? | Yes | 189 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 7 - Are you satisfied with hip? | Yes | 179 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 9 - Are you satisfied with hip? | No | 19 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 8 - Are you satisfied with hip? | No | 17 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 10 - Are you satisfied with hip? | Yes | 206 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 7 - Are you satisfied with hip? | No | 11 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 10 - Are you satisfied with hip? | No | 18 Participants |
| Reflection Ceramic-Ceramic Hip System (IP) | Subject Satisfaction Questionnaire | Year 6 - Are you satisfied with hip? | No | 3 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 10 - Are you satisfied with hip? | No | 4 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 6 - Are you satisfied with hip? | Yes | 25 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 6 - Are you satisfied with hip? | No | 0 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 7 - Are you satisfied with hip? | Yes | 47 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 7 - Are you satisfied with hip? | No | 4 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 8 - Are you satisfied with hip? | No | 3 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 9 - Are you satisfied with hip? | Yes | 49 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 9 - Are you satisfied with hip? | No | 1 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 10 - Are you satisfied with hip? | Yes | 56 Participants |
| Reflection FSO V (5 Hole) (Control) | Subject Satisfaction Questionnaire | Year 8 - Are you satisfied with hip? | Yes | 45 Participants |
Primary
Survival of Hip Implant Based on Number of Hips Requiring Revision
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Time frame: Postoperatively through Year 10
Population: All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RNIA Cohort | 156 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RR Cohort | 0 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RIA Cohort | 17 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RIA Cohort | 2 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RR Cohort | 5 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | CAC Cohort | 15 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | CAC Cohort | 157 Hips |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RNIA Cohort | 12 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | CAC Cohort | 0 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RIA Cohort | 1 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RR Cohort | 0 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | CAC Cohort | 0 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RNIA Cohort | 118 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RIA Cohort | 9 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Not Requiring Revision | RR Cohort | 7 Hips |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Number of Hips Requiring Revision | Hips Requiring Revision | RNIA Cohort | 9 Hips |
Primary
Survival of Hip Implant Based on Time Until Revision Required
The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Time frame: Postoperatively through Year 10
Population: Analysis is presented by individual hip ID numbers to demonstrate time before a revision was required as well as the corresponding cohorts of each. All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 450 (CAC cohort) | 9.9 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 306 (RNIA cohort) | 3.4 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 483 (RNIA cohort) | 3.9 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 167 (RNIA cohort) | 4.1 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 451 (CAC cohort) | 4.2 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 490 (CAC cohort) | 4.2 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 37 (RNIA cohort) | 5.5 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 496 (CAC cohort) | 6.8 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 390 (CAC cohort) | 8.3 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 385 (CAC cohort) | 8.4 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 168 (RNIA cohort) | 0.0 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 221 (RIA cohort) | 0.0 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 348 (CAC cohort) | 0.0 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 408 (CAC cohort) | 0.0 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 448 (CAC cohort) | 0.0 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 113 (RNIA cohort) | 0.1 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 247 (RNIA cohort) | 0.1 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 195 (RNIA cohort) | 0.3 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 218 (RIA cohort) | 0.3 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 458 (CAC cohort) | 0.3 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 370 (CAC cohort) | 0.4 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 398 (CAC cohort) | 0.4 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 471 (RNIA cohort) | 0.7 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 500 (CAC cohort) | 1.1 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 412 (CAC cohort) | 1.3 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 127 (RNIA cohort) | 1.8 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 175 (RNIA cohort) | 2.2 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 204 (RNIA cohort) | 2.5 survival time in years |
| Reflection Ceramic-Ceramic Hip System (IP) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 392 (CAC cohort) | 3.3 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 239 (RNIA cohort) | 0.0 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 318 (RNIA cohort) | 0.0 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 103 (RNIA cohort) | 7.9 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 110 (RNIA cohort) | 6.2 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 337 (RNIA cohort) | 6.5 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 42 (RNIA cohort) | 8.9 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 114 (RNIA cohort) | 6.9 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 308 (RNIA cohort) | 7.0 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 36 (RNIA cohort) | 7.9 survival time in years |
| Reflection FSO V (5 Hole) (Control) | Survival of Hip Implant Based on Time Until Revision Required | Hip ID 288 (RR cohort) | 4.5 survival time in years |