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Completed

NCT Number: NCT03817632

Orthopilot Elite Post-Market Clinical Follow-Up

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

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Key information

Conditions

Degenerative Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Deformity of Knee Immune System Diseases Instability, Joint Joint Diseases Joint Instability Musculoskeletal Diseases Posttraumatic Arthropathy Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Stiffness of Knee, Not Elsewhere Classified

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Carl Gustav Carus, Dresden, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1

Device

Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1

Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0

Device

Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0

Primary outcomes

  1. Rate of Lower Limb Alignment inside the range of 0±3°

    Time frame: three months postoperatively

    A postoperative lower limb alignment of the knee prosthesis in reference to the mechanical leg axis (3, 18) outside the range of ± 3° is defined as the outlier. The outlier rates will be used as the efficacy criterion for groups comparison

Secondary outcomes

  1. Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis

    Time frame: 3 months postoperatively

    The outcome and function of a prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations (23, 24). The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays 3-4 months postoperatively.

  2. Improvement of Knee Society Score (KSS)

    Time frame: preoperatively and three months postoperatively

    The KSS score is composed of two subgroups and has a maximum score of 200.

  3. Improvement of Oxford Knee Score (OKS)

    Time frame: preoperatively and three months postoperatively

    A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function

  4. Improvement of Quality of Life (EQ-5D-5L)

    Time frame: preoperatively and three months postoperatively

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  5. Learning Curve

    Time frame: Intraoperatively

    The first 10 cases of each surgeon shall be excluded from the main analysis. The results of the first 10 cases ("learning curve") shall be assessed separately and compared with the "10 plus" cases ("routine cases") as a secondary learning curve analysis. The potential learning curve will be assessed measuring the intraoperative surgery time in reference to the already performed procedures of each surgeon

  6. Intraoperative handling of soft- and hardware components

    Time frame: Intraoperatively

    Aim of this study is also to document any upcoming problems or limitations the operating surgeon has with the new components of the OrthoPilot® Elite hardware system and the new software application TKA 6.0 for the implantation of primary total knee endoprosthesis. Intraoperatively documented results of the navigation system will be recorded and integrated into the final analysis. Potential problems or comments will be analysed descriptively.

  7. (Serious) Adverse Device Effects

    Time frame: up to 3 months postoperatively

    As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the OrthoPilot® navigation system

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2019
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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