Forgotten Joint Score After Reversed Gap Technique

Total Knee Arthroplasty Clinical Trial

Official title:

Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03044457
• Other study ID #: TCAFJS
• Status: Not yet recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 6, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2017
• Source: University of Jena
• Contact: Georg Matziolis, MD
• Phone: +49 36691 81010
• Email: g.matziolis[@]krankenhaus-eisenberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Clinical Outcome
• Total Knee Arthroplasty

Intervention

Procedure:
• TKA
femoral and tibial positioning using the "reversed gap technique"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forgotten Joint Score 12	clinical score	one year after operation