Musculoskeletal Diseases
Conditions
Keywords
total knee arthroplasty, surgical navigation, medially-stabilized TKA
Brief summary
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
Detailed description
This is a prospective, multicentre, single-arm, open, confirmatory clinical investigation to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA). Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason. The study is conducted according to the following schedule: * V1 : Inclusion during a preoperative visit * V2: Surgery * V3: Follow-up visit at 2 month post-surgery * V4: Follow-up visit at 6 months post-surgery * V5: Follow-up visit at 12 months post-surgery The following data will be collected: * Oxford Knee Score (OKS), Knee Society Score (KSS), Forgotten Joint Score (FJS) and patient satisfaction at 6 months and 12 months of follow-up; * Radiological analysis at 2 and 12 months of follow-up; * Surgical time (min); * Necessity of soft tissue release to obtain ligament or patellar balance; * Time to discharge (days); * Device deficiencies and peri- and postoperative adverse events. A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF). The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
Interventions
DEVICENextAR TKA system
The NextAR TKA system is a surgical guidance system which measures intra-operatively the effect of prosthesis alignment and positioning on soft tissue balance.
Sponsors
Medacta International SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females aged over 18 years at time of surgery. 2. Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked). 3. Patients with functional contralateral knee (i.e. without the need to use walking aids). 4. Patients willing and able to provide written informed consent for participation. 5. Patients willing to comply with the pre and post-operative evaluation schedule.
Exclusion criteria
1. Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study: * Patients presenting with progressive local or systemic infection * Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable. * Severe instability secondary to advanced destruction of condralar structures or loss of integrity of the medial or lateral ligament 2. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. 3. Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity. 4. Patients unable to understand and take action. 5. Patients with known allergy to the materials used. 6. Patients in which Medacta GMK® Sphere system is used in emergency interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | 6 months | Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | 12 months | Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\] |
| Forgotten Joint Score (FJS) | 6 months and 12 months | Forgotten Joint Score (FJS) \[Range: 0-100; higher values indicate better outcomes\] |
| Objective Knee Society Score (KSS) | 6 months and 12 months | Objective Knee Society Score (KSS) \[Range: 0-100; higher values indicate better outcomes; total score reported as the average of subscale scores\] |
| Radiological Outcomes | 2 months and 12 months | X-ray assessment for the evaluation of: implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis |
| Surgical Outcome - Surgical Time | Intraoperative | Surgical time (min) |
| Surgical Outcome - Necessity of Soft Tissue Release | Intraoperative | Necessity of soft tissue release to obtain ligament or patellar balance (Y/N) |
| Surgical Outcome -Time to Discharge | 2 months | Time to discharge (days) |
| Safety Outcomes | Intraoperative, 2 months, 6 months and 12 months | Device deficiencies and adverse events |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORSandro Fucentese, Prof. Dr. med.
Balgrist University Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NextAR TKA Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | NextAR TKA |
|---|---|
| Age, Continuous | 70.0 years |
| Forgotten Joint Score | 15.6 score on a scale |
| Objective Knee Society Score | 45.5 score on a scale |
| Oxford Knee Score | 26.5 score on a scale |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 40 |
| other Total, other adverse events | 5 / 40 |
| serious Total, serious adverse events | 12 / 40 |
Outcome results
Primary
Oxford Knee Score (OKS)
Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\]
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NextAR TKA | Oxford Knee Score (OKS) | 39 scores on a scale |
Secondary
Forgotten Joint Score (FJS)
Forgotten Joint Score (FJS) \[Range: 0-100; higher values indicate better outcomes\]
Time frame: 6 months and 12 months
Population: Lost at 6-month follow up: 1 Lost at 12-month follow up: 2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NextAR TKA | Forgotten Joint Score (FJS) | 6-month follow up | 56.2 score on a scale |
| NextAR TKA | Forgotten Joint Score (FJS) | 12-month follow up | 60.4 score on a scale |
Secondary
Objective Knee Society Score (KSS)
Objective Knee Society Score (KSS) \[Range: 0-100; higher values indicate better outcomes; total score reported as the average of subscale scores\]
Time frame: 6 months and 12 months
Population: Objective KSS. Lost at 6-month follow up: 1. Lost at 12-month follow up: 2.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NextAR TKA | Objective Knee Society Score (KSS) | 6-month follow up | 87.0 score on a scale |
| NextAR TKA | Objective Knee Society Score (KSS) | 12-month follow up | 88.5 score on a scale |
Secondary
Oxford Knee Score (OKS)
Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\]
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NextAR TKA | Oxford Knee Score (OKS) | 41 score on a scale |
Secondary
Radiological Outcomes
X-ray assessment for the evaluation of: implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis
Time frame: 2 months and 12 months
Population: Lost at 12-month follow up: 3
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NextAR TKA | Radiological Outcomes | 2-month follow up | No Radiolucency (>2mm), Subsidence, Loosening | 40 Participants |
| NextAR TKA | Radiological Outcomes | 2-month follow up | Radiolucency (>2mm) - One Gruen Zone | 0 Participants |
| NextAR TKA | Radiological Outcomes | 2-month follow up | Subsidence | 0 Participants |
| NextAR TKA | Radiological Outcomes | 2-month follow up | Loosening | 0 Participants |
| NextAR TKA | Radiological Outcomes | 12-month follow up | No Radiolucency (>2mm), Subsidence, Loosening | 34 Participants |
| NextAR TKA | Radiological Outcomes | 12-month follow up | Radiolucency (>2mm) - One Gruen Zone | 3 Participants |
| NextAR TKA | Radiological Outcomes | 12-month follow up | Subsidence | 0 Participants |
| NextAR TKA | Radiological Outcomes | 12-month follow up | Loosening | 0 Participants |
Secondary
Safety Outcomes
Device deficiencies and adverse events
Time frame: Intraoperative, 2 months, 6 months and 12 months
Secondary
Surgical Outcome - Necessity of Soft Tissue Release
Necessity of soft tissue release to obtain ligament or patellar balance (Y/N)
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NextAR TKA | Surgical Outcome - Necessity of Soft Tissue Release | 0 Participants |
Secondary
Surgical Outcome - Surgical Time
Surgical time (min)
Time frame: Intraoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NextAR TKA | Surgical Outcome - Surgical Time | 60-80 minutes | 3 Participants |
| NextAR TKA | Surgical Outcome - Surgical Time | 81-100 minutes | 18 Participants |
| NextAR TKA | Surgical Outcome - Surgical Time | 101-120 minutes | 13 Participants |
| NextAR TKA | Surgical Outcome - Surgical Time | 121-150 minutes | 6 Participants |
Secondary
Surgical Outcome -Time to Discharge
Time to discharge (days)
Time frame: 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NextAR TKA | Surgical Outcome -Time to Discharge | 4.8 days |