Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS

NCT ID: NCT02522728

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-23
• Study Completion Date: 2017-09-14

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 CR vs. Triathlon PS.

Conditions

Arthroplasty, Replacement, Knee

Study Design

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

Study Groups

Triathlon CR

Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.

Group Type: ACTIVE_COMPARATOR

Triathlon CR

Intervention Type: DEVICE

Implantation of Knee Prosthesis

Triathlon PS

Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.

Group Type: ACTIVE_COMPARATOR

Triathlon PS

Intervention Type: DEVICE

Implantation of Knee Prosthesis

Interventions

Triathlon CR

Implantation of Knee Prosthesis

Intervention Type: DEVICE

Triathlon PS

Implantation of Knee Prosthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients suffering exclusively from osteo arthritis, 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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K-S-015 Triathlon RSA _2

Identifier Type: -

Identifier Source: org_study_id