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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02450409

Enrollment

Registered

2015-05-21

Start date

2014-01-31

Completion date

Unknown

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

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

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.

Interventions

PROCEDUREImplantation of TKA using the gap technique

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

PROCEDUREImplantation of TKA using anatomical alignment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion	intraoperatively immediately before implantation of definite implants.	The outcome measures are given in mm.

Secondary

Measure	Time frame	Description
performance of soft tissue release (yes / no) and extend of release if done.	intraoperatively	The surgeon documents postoeperatively if a soft tissue release was done or not and what extend a release had. The outcome measure is given in numbers (0 ... 4).

Other

Measure	Time frame
The Knee Society Score	1 year postoperatively

Countries

Germany

Contacts

Primary ContactGeorg Matziolis, Prof. Dr.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026