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Active, not recruitingNCT03873363Updated Feb 20, 2024

Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

An interventional study of PS TKA and CR TKA in Knee Osteoarthritis, sponsored by Technische Universität Dresden. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Total Knee Arthroplasty
  • Total Knee Replacement
  • Outcome
  • Implant Design
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 140 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    PS

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

    Device: PS TKA

  • Active comparator
    CR

    Implantation of a cruciate retaining Total Knee Arthroplasty.

    Device: CR TKA

Interventions

  • DevicePS TKA

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

  • DeviceCR TKA

    Implantation of a cruciate retaining Total Knee Arthroplasty.

06

What researchers measure

Primary outcomes

  1. Knee Flexion

    Knee flexion measured using a goniometer

    Time frame: 1 year after surgery

Secondary outcomes

  1. Function assessed by the Knee Society Score

    Knee Society Score

    Time frame: 10 years after surgery

  2. Patient Reported Outcome

    Oxford Knee Score

    Time frame: 10 years after surgery

  3. Health-related Quality of Life

    EQ-5D-3L

    Time frame: 10 years after surgery

  4. Activity assessed by UCLA activity score

    UCLA activity score

    Time frame: 10 years after surgery

Other outcomes

  1. Adverse Events

    Adverse Events

    Time frame: 1 year after surgery

07

Study locations

1 site
  • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
    Dresden, Saxonia 01307, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03873363
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Mar 13, 2019
Start date
Apr 1, 2018
Primary completion
Jun 1, 2020
Completion
Sep 1, 2030 (estimated)
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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