Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit

NCT ID: NCT03198533

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-10
• Study Completion Date: 2017-11-30

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 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.

The evaluation is carried out by a prospective randomised RSA-study with Triathlon PA vs. Triathlon Pressfit

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Triathlon PA

Triathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit.

Group Type: ACTIVE_COMPARATOR

Triathlon PA

Intervention Type: DEVICE

Implantation of Knee Prosthesis

Triathlon Pressfit

Triathlon PA (HA-surface) versus Triathlon Pressfit design: The goal with the un-cemented technique is to reach a full integration between the bone and the prosthesis. During the last years the usage of prosthesis with hydroxyapatite surface within tooth-, mandibular-surgery, hips- and knee-joints, have increased significantly. It has been shown that a thin layer of hydroxyapatite stimulates the anchorage of the implant. The goal with this sub study is to compare the stability of the fixation when using two different types of Triathlon un-cemented prosthesis designs. PA (HA-surface) versus Pressfit.

Group Type: ACTIVE_COMPARATOR

Triathlon Pressfit

Intervention Type: DEVICE

Implantation of Knee Prosthesis

Interventions

Triathlon PA

Implantation of Knee Prosthesis

Intervention Type: DEVICE

Triathlon Pressfit

Implantation of Knee Prosthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients suffering exclusively from OA, Stage II-V [Ahlbäck, 1968 391] 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

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sören Toksvig-Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Locations

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Hässleholm, Skåne County, Sweden

Countries

Sweden

Other Identifiers

K-S-015 Triathlon RSA _3

Identifier Type: -

Identifier Source: org_study_id