Arthritis Knee, Aseptic Loosening
Conditions
Keywords
Bone Cement, Knee Arthroplasty
Brief summary
This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Detailed description
This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.
Interventions
DEVICESimplex HV/Gentamicin Simplex HV bone cement
Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
Sponsors
Stryker Orthopaedics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The Patient is age 18 or over at time of study device implantation * Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label * Patients who have been followed for at least 24 months postoperatively
Exclusion criteria
* Patients who have undergone revision surgery * Patients who have undergone bilateral Knee Arthroplasty * Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use * Patient has a cementless tibial baseplate. * Patient has an active or suspected latent infection in or about the affected knee joint * Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days) * Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure * Patient is a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Application of Bone Cement | 24 months | A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KSS Pain Motion Score: Pain | Pre-operative, 2 years, 5 years (optional) | This section shows a five-level pain measurement from no pain to severe pain reported by the subjects. |
| KSS Function Score: Walking Aids | Pre-operative, 2 years, 5 years (optional) | Pre- and postoperative use of walking aids |
| KSS Function Score: Walking | pre-operative, 2 years, 5 years (optional) | Pre- and post-operative walking ability |
| Knee Society Score (KSS) Pain Motion Score: Range of Motion | pre-op, 2 years, 5 years (optional) | The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg). |
| Oxford Knee Score (OKS) Results | pre-op, 2 years, 5 years (optional) | The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function. |
| KSS Pain Motion Score: Stability | pre-operative, 2 years, 5 years (optional) | This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability \< 5 mm and medio-lateral (m/l) stability \< 5° means mild increase in laxity compared to the contralateral knee. |
| KSS Function Score: Stairs | Pre-operative, 2 years, 5 years (optional) | Pre-and postoperative ability of climbing stairs |
Participant flow
Recruitment details
This was a retrospective study with planned 100 subjects per group. Recruitment was stopped in the Non-medicated Simplex HV group with 97 subjects because there were no additional eligible subjects.
Pre-assignment details
In the non-medicated Simplex HV group further three of the 97 subjects were excluded after enrollment as two subjects did not receive the study device and one subject met an exclusion criterion (Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days))
Participants by arm
| Arm | Count |
|---|---|
| Non-medicated Simplex HV Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. | 95 |
| Gentamicin Simplex HV Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Simplex HV Bone Cement with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. | 101 |
| Total | 196 |
Baseline characteristics
| Characteristic | Gentamicin Simplex HV | Total | Non-medicated Simplex HV |
|---|---|---|---|
| Age, Customized | 71.8 years STANDARD_DEVIATION 7.83 | 68.97 years STANDARD_DEVIATION 8.83 | 66 years STANDARD_DEVIATION 8.84 |
| BMI | 30.5 kg/m^2 STANDARD_DEVIATION 4.73 | 31.87 kg/m^2 STANDARD_DEVIATION 5.53 | 33.3 kg/m^2 STANDARD_DEVIATION 5.94 |
| Height cm | 166 centimeter STANDARD_DEVIATION 9.24 | 165.4 centimeter STANDARD_DEVIATION 9.7 | 165 centimeter STANDARD_DEVIATION 10.17 |
| Operative side Left side | 44 Participants | 91 Participants | 47 Participants |
| Operative side Right side | 57 Participants | 105 Participants | 48 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 101 Participants | 101 Participants | 0 Participants |
| Region of Enrollment United States | 0 Participants | 95 Participants | 95 Participants |
| Sex: Female, Male Female | 58 Participants | 123 Participants | 65 Participants |
| Sex: Female, Male Male | 43 Participants | 73 Participants | 30 Participants |
| Weight kg | 83.4 kilogram STANDARD_DEVIATION 14.82 | 87.1 kilogram STANDARD_DEVIATION 17.71 | 91.0 kilogram STANDARD_DEVIATION 19.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 101 |
| other Total, other adverse events | 18 / 95 | 9 / 101 |
| serious Total, serious adverse events | 10 / 95 | 21 / 101 |
Outcome results
Primary
Number of Participants With Successful Application of Bone Cement
A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-medicated Simplex HV | Number of Participants With Successful Application of Bone Cement | 95 Participants |
| Gentamicin Simplex HV | Number of Participants With Successful Application of Bone Cement | 101 Participants |
Secondary
Knee Society Score (KSS) Pain Motion Score: Range of Motion
The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg).
Time frame: pre-op, 2 years, 5 years (optional)
Population: The retrospective study approach did not allow for full KSS data collection. Range of motion data available were collected for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-medicated Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | Pre-op Range of motion (ROM) | 108.59 degrees | Standard Deviation 12.74 |
| Non-medicated Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | 2 years ROM | 110.48 degrees | Standard Deviation 12.48 |
| Non-medicated Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | 5 years ROM | 113.37 degrees | Standard Deviation 13.35 |
| Gentamicin Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | Pre-op Range of motion (ROM) | 101.16 degrees | Standard Deviation 14.19 |
| Gentamicin Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | 2 years ROM | 110.32 degrees | Standard Deviation 11.4 |
| Gentamicin Simplex HV | Knee Society Score (KSS) Pain Motion Score: Range of Motion | 5 years ROM | 114.81 degrees | Standard Deviation 8.74 |
Secondary
KSS Function Score: Stairs
Pre-and postoperative ability of climbing stairs
Time frame: Pre-operative, 2 years, 5 years (optional)
Population: The retrospective study approach did not allow for full KSS data collection. Stair climbing ability data available were collected for analysis of non-medicated Simplex HV only.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Non-medicated Simplex HV | KSS Function Score: Stairs | Pre-operative ability to climb stairs | Unable | 22 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Pre-operative ability to climb stairs | Up with rail/unable down | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Pre-operative ability to climb stairs | Up and down with rail | 12 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Pre-operative ability to climb stairs | Normal up/down with rail | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Pre-operative ability to climb stairs | Normal up and down | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 2 years | Unable | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 2 years | Up with rail/unable down | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 2 years | Up and down with rail | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 2 years | Normal up/down with rail | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 2 years | Normal up and down | 15 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 5 years | Unable | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 5 years | Up with rail/unable down | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 5 years | Up and down with rail | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 5 years | Normal up/down with rail | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Stairs | Ability to climb stairs at 5 years | Normal up and down | 13 Participants |
Secondary
KSS Function Score: Walking
Pre- and post-operative walking ability
Time frame: pre-operative, 2 years, 5 years (optional)
Population: The retrospective study approach did not allow for full KSS data collection. Walking ability data available were collected for analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Below 5 blocks (<500m/<1640 feet) | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | 5-10 blocks (500m - 1000m/1640-3280 feet) | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | 5-10 blocks (500m - 1000m/1640-3280 feet) | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Housebound | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Over 10 blocks (>1000m/>3280 feet) | 3 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Over 10 blocks (>1000m/>3280 feet) | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Unlimited | 17 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Below 5 blocks (<500m/<1640 feet) | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Housebound | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Unlimited | 1 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | 5-10 blocks (500m - 1000m/1640-3280 feet) | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Below 5 blocks (<500m/<1640 feet) | 48 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Over 10 blocks (>1000m/>3280 feet) | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Housebound | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Unlimited | 13 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Unlimited | 2 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Housebound | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Below 5 blocks (<500m/<1640 feet) | 13 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | 5-10 blocks (500m - 1000m/1640-3280 feet) | 7 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Over 10 blocks (>1000m/>3280 feet) | 2 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Pre-operative walking ability | Unlimited | 2 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Housebound | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Below 5 blocks (<500m/<1640 feet) | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | 5-10 blocks (500m - 1000m/1640-3280 feet) | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Over 10 blocks (>1000m/>3280 feet) | 1 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 2 years | Unlimited | 2 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Below 5 blocks (<500m/<1640 feet) | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | 5-10 blocks (500m - 1000m/1640-3280 feet) | 1 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Over 10 blocks (>1000m/>3280 feet) | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking | Walking ability at 5 years | Housebound | 0 Participants |
Secondary
KSS Function Score: Walking Aids
Pre- and postoperative use of walking aids
Time frame: Pre-operative, 2 years, 5 years (optional)
Population: The retrospective study approach did not allow for full KSS data collection. Use of walking aids data available were collected for analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 5 years | None | 30 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | None | 43 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Cane | 13 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Two canes, one crutch | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 5 years | Cane | 8 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 5 years | Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair | 2 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 5 years | Two canes, one crutch | 0 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | None | 52 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Cane | 23 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair | 3 Participants |
| Non-medicated Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Two canes, one crutch | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | None | 2 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | None | 9 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Cane | 12 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair | 1 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Cane | 0 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Pre-operative walking aids use | Two canes, one crutch | 1 Participants |
| Gentamicin Simplex HV | KSS Function Score: Walking Aids | Walking aids use at 2 years | Two canes, one crutch | 0 Participants |
Secondary
KSS Pain Motion Score: Pain
This section shows a five-level pain measurement from no pain to severe pain reported by the subjects.
Time frame: Pre-operative, 2 years, 5 years (optional)
Population: The retrospective study approach did not allow for full KSS data collection. Pain data available were collected for analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Severe pain | 0 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Moderate continual pain | 3 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Moderate occasional pain | 24 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Moderate occasional pain | 4 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Mild or occasional pain | 11 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | No pain | 29 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Severe pain | 21 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Mild or occasional pain | 17 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | No pain | 0 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Moderate continual pain | 1 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | No pain | 49 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Moderate occasional pain | 2 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Moderate continual pain | 34 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Severe pain | 0 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Mild or occasional pain | 26 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Severe pain | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | No pain | 1 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Mild or occasional pain | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Moderate continual pain | 6 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Moderate occasional pain | 1 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pre-operative Pain | Severe pain | 18 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | No pain | 2 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Mild or occasional pain | 5 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Moderate continual pain | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Severe pain | 1 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | No pain | 6 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Mild or occasional pain | 2 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Moderate continual pain | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 5 years | Moderate occasional pain | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Pain | Pain at 2 years | Moderate occasional pain | 0 Participants |
Secondary
KSS Pain Motion Score: Stability
This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability \< 5 mm and medio-lateral (m/l) stability \< 5° means mild increase in laxity compared to the contralateral knee.
Time frame: pre-operative, 2 years, 5 years (optional)
Population: The retrospective study approach in the Non-medicated Simplex HV study arm did not allow for full KSS Stability data collection as not all data were collected at 2 and 5 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-medicated Simplex HV | KSS Pain Motion Score: Stability | preoperative a/p <5mm and m/l <5° stability | 87 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Stability | 2 years a/p <5mm and m/l <5° stability | 81 Participants |
| Non-medicated Simplex HV | KSS Pain Motion Score: Stability | 5 years a/p <5mm and m/l <5° stability | 52 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Stability | 2 years a/p <5mm and m/l <5° stability | 0 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Stability | preoperative a/p <5mm and m/l <5° stability | 1 Participants |
| Gentamicin Simplex HV | KSS Pain Motion Score: Stability | 5 years a/p <5mm and m/l <5° stability | 0 Participants |
Secondary
Oxford Knee Score (OKS) Results
The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function.
Time frame: pre-op, 2 years, 5 years (optional)
Population: Due to the retrospective study approach, the site of the Non-medicated Simplex HV arm did not collect OKS data and therefore OKS data cannot be presented for this site, whereas the site for the Gentamicin Simplex HV arm did collect OKS data which are presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gentamicin Simplex HV | Oxford Knee Score (OKS) Results | pre-operative OKS | 18.96 score on a scale | Standard Deviation 7.79 |
| Gentamicin Simplex HV | Oxford Knee Score (OKS) Results | 2 years OKS | 39.27 score on a scale | Standard Deviation 7.92 |
| Gentamicin Simplex HV | Oxford Knee Score (OKS) Results | 5 years OKS | 39.38 score on a scale | Standard Deviation 7.73 |