Forgotten Joint Score After Reversed Gap Technique

NCT ID: NCT03044457

Last Updated: 2017-02-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-08-01

Brief Summary

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A new operation technique was established ("reversed gap technique" for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional "gap technique" as control in a RCT study.

Detailed Description

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Conditions

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Total Knee Arthroplasty Clinical Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: "reversed gap technique" vs. "gap technique", randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
neither the participant nor the outcome assessor know the group. The surgeon of course knows.

Study Groups

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TKA by reversed gap technique

new operative technique of positioning the femoral and tibial component based on soft tissue tension and femoral 3D geometry.

Group Type EXPERIMENTAL

TKA

Intervention Type PROCEDURE

femoral and tibial positioning using the "reversed gap technique"

TKA by gap technique

standard operative technique serving as control. tibia component positioning according to the mechanical axis, femoral component positioning according to the mechanical axis and soft tissue tension in flexion

Group Type ACTIVE_COMPARATOR

TKA

Intervention Type PROCEDURE

femoral and tibial positioning using the "reversed gap technique"

Interventions

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TKA

femoral and tibial positioning using the "reversed gap technique"

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* indication for implantation a total knee arthroplasty

Exclusion Criteria

* indication for a constrained implant
* secondary type of arthritis (rheumatoid, post traumatic, post infectious)
* former "open" surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Georg Matziolis

Director of the Orthopaedic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Georg Matziolis, MD

Role: CONTACT

+49 36691 81010

Other Identifiers

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TCAFJS

Identifier Type: -

Identifier Source: org_study_id

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