Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Standard vs. Short Keel

NCT02525614 | Completed

• 1 other identifier: K-S-015 Triathlon RSA _4
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)

  Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric as a predictor of late mechanical loosening.

  10 years follow-up

Secondary Outcomes (4)

• Investigation of patient outcome with radiographic analysis

  3 months, 1, 2, 5, 7 and 10 years

• Investigation of clinical performance and patient outcome with KSS (Knee Society Score)

  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

• Investigation of clinical performance and patient outcome with EQ-5D patient questionnaire

  pre-operative, 3 months, 1, 2, 5, 7 and 10 years

Study Arms (2)

Triathlon Standard Keel

ACTIVE COMPARATOR

Triathlon Cruciate Retaining knee (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel.

Device: Triathlon Standard Keel

Triathlon Short Keel

ACTIVE COMPARATOR

Triathlon Cruciate Retaining knee (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel.

Device: Triathlon Short Keel

Interventions

Triathlon Standard Keel DEVICE

Implantation of Knee Prosthesis

Triathlon Standard Keel

Triathlon Short Keel DEVICE

Implantation of Knee Prosthesis

Triathlon Short Keel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Patients with other severe concurrent joint involvements, which can affect their outcome.
• 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.
• Patients under the protection of law (e.g. guardianship).

Sponsors & Collaborators

• Region Skane: lead

Study Officials

• Sören Toksvig-Larsen, MD

  Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 17, 2015
• Study Start: May 1, 2009
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: June 27, 2025

Record last verified: 2023-03