Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented

NCT02525601 | Active Not Recruiting

• 1 other identifier: K-S-015 Triathlon RSA _5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; UPDATE: time frame extended up to 15 years outcomes

Secondary Outcomes (4)

• Investigation of patient outcome with radiographic analysis

  3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years

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

  pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years

• Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire

  pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years

• Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire

  pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years

Study Arms (2)

Triathlon CR cemented

ACTIVE COMPARATOR

Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented Peri-Apatite (PA) knee fixation and migration properties versus the cemented version.

Device: Triathlon CR cemented

Triathlon CR uncemented

ACTIVE COMPARATOR

Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented PA knee fixation and migration properties versus the cemented version.

Device: Triathlon CR uncemented

Interventions

Triathlon CR cemented DEVICE

Implantation of Knee Prosthesis

Triathlon CR cemented

Triathlon CR uncemented DEVICE

Implantation of Knee Prosthesis

Triathlon CR uncemented

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 osteo arthritis, Stage II-V \[Ahlbäck Trauma Score, 1968 391\] 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 Sites (1)

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Hässleholm, Skåne County, 281 38, Sweden

Location

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: March 1, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-09

Locations

SE (1)