Forgotten Joint Score After Reversed Gap Technique

University of Jena

Status: Unknown

Conditions: Clinical Outcome; Total Knee Arthroplasty

Treatments: Procedure: TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT03044457

TCAFJS

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

TKA by reversed gap technique

Experimental group

Description:

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

Treatment:

Procedure: TKA

TKA by gap technique

Active Comparator group

Description:

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

Treatment:

Procedure: TKA