Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)

NCT00839020 | Terminated Phase 4

• 1 other identifier: MIOS-TKR
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis

Keywords

Surgical Procedures, Minimally Invasive; Range of Motion; Articular Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.

  daily measurements for 20 postoperative days

Secondary Outcomes (4)

• Range of Motion (ROM)

  daily measurements during hospital stay

• Knee Society Score (KSS)

  preop, postop

• Oxford Knee Score (OKS)

  preop, postop

• WOMAC-Score

  preop, postop

Study Arms (2)

1

ACTIVE COMPARATOR

Navigated total knee arthroplasty with a minimally invasive approach

Procedure: Navigated TKA with a minimally invasive approach

2

ACTIVE COMPARATOR

Navigated total knee arthroplasty with a conventional approach

Procedure: Navigated TKA with a conventional approach

Interventions

Navigated TKA with a minimally invasive approach PROCEDURE

Navigated total knee arthroplasty with a minimally invasive approach

Also known as: Navigated MIS TKA

1

Navigated TKA with a conventional approach PROCEDURE

A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed

Also known as: Navigated TKA with conventional approach

2

Eligibility Criteria

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

You may qualify if:

• Indication for elective TKA
• agreement to participate in this study

You may not qualify if:

• Body Mass Index (BMI)\>40kg/m²
• varus or valgus deformity \>20°
• Range of Motion (ROM) \<75° flexion/extension
• concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee
• infections in the operated joint during the follow-up period
• Thromboses during the follow-up period

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Frank Lampe, MD

Hamburg, Germany

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frank Lampe, MD

  Schön Kliniken Klinikum Eilbek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: November 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

DE (1)