Clinical trial NCT00431509: Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery
Official title: A Randomized Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery. Influence on Operative Result, Health-Related Quality of Life, and Coordinative Abilities.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Arthroplasty
Replacement
Knee
Instrumentation
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: DePuy International
First posted: 2007-02-05
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities.

One group of patients will receive navigated knee implantation surgery, the other traditional knee implantation surgery, without use of the navigation system.

The study is designed as a randomized trial. That means that all patients who have given their consent to participate in this study will be allocated to either navigated or conventional surgery by chance.

A total of 477 patients will be included in this study and will be followed up for 12 month.

In this period all patients will be asked to fill in functional and quality of life questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities will be evaluated once in the time-frame 3 to 6 months postoperatively.

Detailed description: Various risk factors influencing the success of Total Knee Arthroplasty (TKA) have been studied.

Today age, gender, primary or revision surgery, comorbidities and baseline characteristics are known to influence the health-related quality of life after TKA.

It is thought, that accurate mechanical alignment and ligament balance ensure optimal kinematic performance and wear, which in turn improves long-term outcome.

During preparation of the bone for the implantation of the knee prosthesis, numerous cuts are performed. Traditionally mechanical adjusted jigs are used to accurately align and position the instruments.

Since this alignment process is a source for deviation even in experienced surgeons, several navigation systems were developed. Using these systems, the surgeon is guided in the location of the instruments with the help of a computer.

Several studies could show that the use of such a navigation system leads to an improved execution of planned axis relations, as measured on the radiographs. However, it is not clear, whether or to what extent the improved realization of the preoperative planned axis relations results in a positive effect for the patient.

This multicenter randomized clinical trail is conducted to compare the operative results of navigated and non-navigated knee replacement surgery.

The aim of this study is to evaluate the use of a navigation system on health-related quality of life, measured as pain, stiffness, physical function, coordinative abilities, and patient satisfaction.

The hypotheses tested is that the use of the navigation system for total knee arthroplasty leads to improved health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* All patients who are scheduled to receive a Total Knee Arthroplasty at the participating institutions for primary diagnosis of osteoarthritis are candidates for inclusion in the study.

Exclusion Criteria:

* A history of septic arthritis in the joint to operate
* Amputations
* Neurological deficits
* Inability to complete the questionnaires because of cognitive or language difficulties
* Prior knee arthroplasty in the joint to operate
* Prior arthroplasty in another weight-bearing joint within the last 6 months

Primary outcomes:
measure: Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
Secondary outcomes:
measure: Leg-specific pain and stiffness as measured with the WOMAC
measure: The Lequesne Knee Score
measure: The physical component summary of the SF-36
measure: EuroQoL-5D
measure: Patient satisfaction
measure: Balance abilities as investigated with the Biodex Stability System®
measure: Motoric coordination as assessed by a shortened version of the "Dortmunder modified Romberg Test for Seniors"
measure: Proprioception assessed according to guidelines established by Barrack and Swanik
measure: Axis relations evaluated by postoperative standardized lateral and AP X-rays
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University of Mannheim, Center for Orthopaedic Surgery and Traumatology
state: Baden-Wuerttemberg
city: Bad Abbach
country: Germany
facility: University of Regensburg, Department of Orthopaedic Surgery
state: Bavaria
city: Würzburg
country: Germany
facility: University of Würzburg, Department of Orthopaedic Surgery
state: Bavaria
city: Cologne
country: Germany
facility: University of Cologne, Department of Orthopaedic Surgery
state: Northrhine-Westfalia
city: Kiel
country: Germany
facility: University of Schleswig-Holstein, Kiel Medical Center
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Center for Musculoskeletal Surgery
city: Bremen
country: Germany
facility: DIAKO Ev. Diakonie-Hospital gGmbH, Clinic for Orthopaedic Surgery and Traumatology
city: Hamburg
country: Germany
facility: Schön-Klinikum Hamburg-Eilbek, Department of Orthopedic Surgery and Traumatology
Study officials:
affiliation: University of Schleswig-Holstein, Kiel Medical Center
name: Joachim Hassenpflug, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Schleswig-Holstein, Kiel Medical Center
name: Thoralf R Liebs, Dr.
role: PRINCIPAL_INVESTIGATOR
References: