Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

NCT ID: NCT03873363

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2030-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to one of two surgical techniques.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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PS

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

Group Type EXPERIMENTAL

PS TKA

Intervention Type DEVICE

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

CR

Implantation of a cruciate retaining Total Knee Arthroplasty.

Group Type ACTIVE_COMPARATOR

CR TKA

Intervention Type DEVICE

Implantation of a cruciate retaining Total Knee Arthroplasty.

Interventions

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PS TKA

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

Intervention Type DEVICE

CR TKA

Implantation of a cruciate retaining Total Knee Arthroplasty.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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TKA CR vs PS

Identifier Type: -

Identifier Source: org_study_id

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