Clinical trial NCT03817632: Orthopilot Elite Post-Market Clinical Follow-Up
Official title: Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Osteoarthritis
Rheumatoid Arthritis
Posttraumatic Arthropathy
Instability, Joint
Stiffness of Knee, Not Elsewhere Classified
Deformity of Knee
Keywords: Navigation
Computer Assisted Orthopedic Surgery
OrthoPilot®
Total Knee Arthroplasty
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty

Detailed description: The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation \>3° from neutral alignment is defined as an outlier.

Eligibility criteria: Inclusion: Inclusion Criteria:

* Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
* Dated and signed informed consent

Exclusion: Exclusion Criteria

* Pregnancy
* Patients \< 18 years
* Patients unable to participate at the follow-up examination (physically, mentally)
* Previous joint replacement at the indexed knee

Primary outcomes:
measure: Rate of Lower Limb Alignment inside the range of 0±3°
timeFrame: three months postoperatively
Secondary outcomes:
measure: Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis
timeFrame: 3 months postoperatively
measure: Improvement of Knee Society Score (KSS)
timeFrame: preoperatively and three months postoperatively
measure: Improvement of Oxford Knee Score (OKS)
timeFrame: preoperatively and three months postoperatively
measure: Improvement of Quality of Life (EQ-5D-5L)
timeFrame: preoperatively and three months postoperatively
measure: Learning Curve
timeFrame: Intraoperatively
measure: Intraoperative handling of soft- and hardware components
timeFrame: Intraoperatively
measure: (Serious) Adverse Device Effects
timeFrame: up to 3 months postoperatively
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Freiburg
country: Germany
facility: Uniklinikum Freiburg
city: Hamburg
country: Germany
facility: Schönkliniken Klinikum Eilbek
Study officials:
References: