Forgotten Joint Score After Reversed Gap Technique

Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Arthroplasty; Clinical Outcome
• Intervention / Treatment: Procedure: TKA

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georg Matziolis, MD; Phone Number: +49 36691 81010; Email: g.matziolis@krankenhaus-eisenberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TKA by reversed gap technique; new operative technique of positioning the femoral and tibial component based on soft tissue tension and femoral 3D geometry.	Procedure: TKA; femoral and tibial positioning using the "reversed gap technique"
Active Comparator: 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	Procedure: TKA; femoral and tibial positioning using the "reversed gap technique"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forgotten Joint Score 12	clinical score	one year after operation

Collaborators and Investigators

• Sponsor: University of Jena

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TCAFJS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No