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NCT Number: NCT04728542

ORIGIN® vs. VANGUARD® PS Observational Study

The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, 55131, Germany

Location status: Recruiting

Location contact

Lukas Eckhard

CONTACT

Philipp Drees, Dr

CONTACT

About this study

This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion/exclusion criteria

Treatment and study plan

ORIGIN PS System

Device

70 surgeries with the ORIGIN PS System

VANGUARD PS System

Device

70 surgeries with the VANGUARD System

Primary outcomes

  1. Forgotten Joint Score

    Time frame: Preoperative, 1 year, and 2 years visits

    12 questions and measure the ability of the patient to forget their operated knee after the surgery.

  2. The Self-Administered Patient Satisfaction Scale

    Time frame: Preoperative, 1 year, and 2 years visits

    Patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities.

Secondary outcomes

  1. Oxford Knee Score (OKS)

    Time frame: Preoperative, 1 year, and 2 years visits

    Patient reported scores This Quality of Life score was developed in 1998 and validated to measure pain and function after total knee replacement. It consists of 12 questions about pain, function and mobility of the knee joint.

    Each question scores from 1 to 5 (1 the best and 5 the worst) and the sum of all the scores is deducted from 60 points. The best total is 48 points and the worst is 0.

  2. EQ-5D-5L

    Time frame: Preoperative, 1 year, and 2 years visits

    Patient reported scores.

    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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. 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.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  3. Knee Society clinical rating system (KSS) Objective Knee Indicators

    Time frame: Preoperative, 1 year, and 2 years visits

    Surgeon reported score.

    It consists of 4 questions regarding the alignment and mobility of the knee joint:

    "Alignment" has a maximum of 25 points and is determined on a weight-bearing AP radiograph measuring the femoral-tibial (Anatomic) axis.

    "Instability" allows a maximum of 25 points for a knee that is stable in the coronal and saggital axis.

    "Joint Motion" allows one point for each 5° of joint motion. Unlike the old scoring system that allowed a maximum of 25 points the new system allows greater than 25 points for patients with greater than 125° of motion. There are deductions for flexion contracture and extension lag. The presence of recurvatum is not specifically addressed however patients with recurvatum will have significant ligament laxity in other planes that is captured in the

    "Instability" category of the objective score. Maximum allowable points 25+

  4. Single Leg Stance test

    Time frame: Preoperative, 1 year, and 2 years visits

    Surgeon reported score. It is used to assess static postural and balance control. It is a balance assessement that is widely used in clinical settings to monitor neurological and musculoskeletal conditions.

    It measures the duration of exercices with eyes opened and closed in seconds.

  5. Time Up & Go tests

    Time frame: Preoperative, 1 year, and 2 years visits

    Surgeon reported score It is a simple test to assess a person's mobility and requires both static and dynamic balance (e.g. Getting up from a chair with armrests, Make a U turn...) The criteria are : able - unable

Study contacts

Contact information is provided by the study sponsor or research team.

Lukas Eckhard

CONTACT

[email protected]

+496131177302

Sponsors and collaborators

Lead sponsor

Symbios Orthopedie SA

Industry

Registry information

Official study title

A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 28, 2021
Registry last updated
Oct 4, 2024

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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