Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series

Stryker Orthopaedics1 site in 1 country60 target enrollmentFebruary 2006

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics
Enrollment: 60
Locations: 1
Primary Endpoint: Roentgen Stereophotogrammetric Analysis (RSA)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

Detailed Description

The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

January 4, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stryker Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] will be operated.
•Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
•Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
•Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria

•Previous major knee surgery
•Other significant disabling problems from the muscular-skeletal system than in the knees
•Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
•Patients with active or suspected infection.
•Patients with malignancy - active malignancy.
•Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
•Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
•The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
•Female patients planning a pregnancy during the course of the study.
•Patients with systemic or metabolic disorders leading to progressive bone deterioration.

Outcomes

Primary Outcomes

Roentgen Stereophotogrammetric Analysis (RSA)

Time Frame: 2 years

To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.

Secondary Outcomes

Blood Loss(intra-operative)
Duration Hospital Stay(preoperative to discharge)
Roentgen Stereophotogrammetric Analysis (RSA)(3 months, 1, 5, 7 and 10 years)
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)([Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years])
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
Mean Operative Time(intra-operative)