Evaluation of Triathlon - a New Total Knee Prosthesis System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2017-01-04

Brief Summary

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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.

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Detailed Description

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

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cemented Triathlon total knee system

The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.

Group Type ACTIVE_COMPARATOR

Cemented Triathlon total knee system

Intervention Type DEVICE

Orthopaedic implant

Cemented Duracon total knee system

The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.

Group Type ACTIVE_COMPARATOR

Duracon total knee system

Intervention Type DEVICE

Orthopaedic implant

Interventions

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Cemented Triathlon total knee system

Orthopaedic implant

Intervention Type DEVICE

Duracon total knee system

Orthopaedic implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] will be operated.
2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
3. 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.
4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria

1. Previous major knee surgery
2. Other significant disabling problems from the muscular-skeletal system than in the knees
3. 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).
4. Patients with active or suspected infection.
5. Patients with malignancy - active malignancy.
6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. 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.
9. Female patients planning a pregnancy during the course of the study.
10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
12. Patients with other severe concurrent joint involvements, which can affect their outcome.
13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
14. Patients under the protection of law (e.g. guardianship).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No