NCT03873363

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
52mo left

Started Apr 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2018Sep 2030

Study Start

First participant enrolled

April 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Expected
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

March 7, 2019

Last Update Submit

February 16, 2024

Conditions

Knee Osteoarthritis

Keywords

Total Knee ArthroplastyTotal Knee ReplacementOutcomeImplant Design

Outcome Measures

Primary Outcomes (1)

  • Knee Flexion

    Knee flexion measured using a goniometer

    1 year after surgery

Secondary Outcomes (4)

  • Function assessed by the Knee Society Score

    10 years after surgery

  • Patient Reported Outcome

    10 years after surgery

  • Health-related Quality of Life

    10 years after surgery

  • Activity assessed by UCLA activity score

    10 years after surgery

Other Outcomes (1)

  • Adverse Events

    1 year after surgery

Study Arms (2)

PS

EXPERIMENTAL

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

Device: PS TKA

CR

ACTIVE COMPARATOR

Implantation of a cruciate retaining Total Knee Arthroplasty.

Device: CR TKA

Interventions

PS TKADEVICE

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

PS
CR TKADEVICE

Implantation of a cruciate retaining Total Knee Arthroplasty.

CR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to one of two surgical techniques.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 13, 2019

Study Start

April 1, 2018

Primary Completion

June 1, 2020

Study Completion (Estimated)

September 1, 2030

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

DE(1)