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Active, Not Recruiting

NCT Number: NCT03873363

Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Dresden, Saxony, 01307, Germany

About this study

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for TKA with a non-linked, bicondylar total knee replacement
  • written informed consent

Exclusion criteria

  • Chronic pain patients
  • Neuromuscular Diseases
  • general illnesses that make mobilisation more difficult and/or prevent follow-up
  • Known posterior cruciate ligament insufficiency
  • Need for a higher degree of linkage
  • BMI over 40 kg/m²
  • Study doctor, his family, employees or other dependent persons

Treatment and study plan

PS TKA

Device

Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.

CR TKA

Device

Implantation of a cruciate retaining Total Knee Arthroplasty.

Primary outcomes

  1. Knee Flexion

    Time frame: 1 year after surgery

    Knee flexion measured using a goniometer

Secondary outcomes

  1. Function assessed by the Knee Society Score

    Time frame: 10 years after surgery

    Knee Society Score

  2. Patient Reported Outcome

    Time frame: 10 years after surgery

    Oxford Knee Score

  3. Health-related Quality of Life

    Time frame: 10 years after surgery

    EQ-5D-3L

  4. Activity assessed by UCLA activity score

    Time frame: 10 years after surgery

    UCLA activity score

Other outcomes

  1. Adverse Events

    Time frame: 1 year after surgery

    Adverse Events

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty

Important dates

Study start
2018
Primary completion
2020
Study completion
2030
First posted
Mar 13, 2019
Registry last updated
Feb 20, 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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