Forgotten Joint Score After Reversed Gap Technique

NCT03044457 | Unknown

• 1 other identifier: TCAFJS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Total Knee Arthroplasty; Clinical Outcome

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score 12

  clinical score

  one year after operation

Study Arms (2)

TKA by reversed gap technique

EXPERIMENTAL

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

Procedure: TKA

TKA by gap technique

ACTIVE COMPARATOR

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

Interventions

TKA PROCEDURE

femoral and tibial positioning using the "reversed gap technique"

TKA by gap technique; TKA by reversed gap technique

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for implantation a total knee arthroplasty

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Jena: lead

Central Study Contacts

Georg Matziolis, MD

CONTACT

+49 36691 81010; g.matziolis@krankenhaus-eisenberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: neither the participant nor the outcome assessor know the group. The surgeon of course knows.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Orthopaedic Department

Model Details: Two groups: "reversed gap technique" vs. "gap technique", randomized

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share