A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty

NCT02450409 | Unknown

• 1 other identifier: REK_2015_1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.

Conditions

Osteoarthritis, Knee

Keywords

Total knee arthroplasty; Midflexion instability; Gap technique; Anatomical alignment

Outcome Measures

Primary Outcomes (1)

• Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion

  The outcome measures are given in mm.

  intraoperatively immediately before implantation of definite implants.

Secondary Outcomes (1)

• performance of soft tissue release (yes / no) and extend of release if done.

  intraoperatively

Other Outcomes (1)

• The Knee Society Score

  1 year postoperatively

Study Arms (2)

gap technique (GT)

ACTIVE COMPARATOR

The patients receive a total knee arthroplasty using the established "gap technique" (gold standard serving as control). The intervention is the implantation of a total knee arthroplasty with this specific technique. Implantation of TKA using the gap technique is the intervention. Intervention is not a drug but a specific operative technique.

Procedure: Implantation of TKA using the gap technique

anatomical alignment (AA)

EXPERIMENTAL

The patients receive a total knee arthroplasty using the new "anatomical alignment technique" (experimental). The intervention is the implantation of a total knee arthroplasty with this specific technique. Implantation of TKA using anatomical alignment Intervention is not a drug but a specific operative technique.

Procedure: Implantation of TKA using anatomical alignment

Interventions

Implantation of TKA using the gap technique PROCEDURE

Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.

gap technique (GT)

Implantation of TKA using anatomical alignment PROCEDURE

Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.

anatomical alignment (AA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients were to undergo surface replacement due to primary osteoarthritis of the knee

You may not qualify if:

• Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Friedrich-Schiller University Jena, Campus Eisenberg

Eisenberg, Eisenberg, 07607, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Georg Matziolis, Prof. Dr.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 21, 2015
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

DE (1)