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CompletedNCT03198533TriathlonRSAUpdated Feb 21, 2024

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

An interventional study of Triathlon PA and Triathlon Pressfit in Arthroplasty, Replacement, Knee, sponsored by Stryker Orthopaedics. Completed at 1 site in Sweden. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Stryker Orthopaedics · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 years 9 months after the study started (first participant enrolled Jul 2007, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Arthroplasty, Replacement, Knee

Keywords

  • Knee
  • Arthrosis
  • Implant
03

In context

Lead sponsor

Stryker Orthopaedics is the lead sponsor of 44 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    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.

    Device: Triathlon PA

  • Active comparator
    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.

    Device: Triathlon Pressfit

Interventions

  • DeviceTriathlon PA

    Implantation of Knee Prosthesis

  • DeviceTriathlon Pressfit

    Implantation of Knee Prosthesis

06

What researchers measure

Primary outcomes

  1. Roentgen Stereophotogrammetric Analysis (RSA)

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

    Time frame: 10 years follow-up

Secondary outcomes

  1. Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)

    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

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

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

    KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

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

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

    The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

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

  4. Investigation of patient outcome with radiographic analysis

    Plain radiographs will be obtained for assessment of fixation of the device.

    Time frame: 3 months, 1, 2, 5, 7 and 10 years

07

Study locations

1 site
  • Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
    Hässleholm, Skåne Län 281 38, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03198533
Lead sponsor
Stryker Orthopaedics
Responsible party
Sponsor
First posted
Jun 26, 2017
Start date
Jul 10, 2007
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017
Last update
Feb 21, 2024

Study contacts

Sören Toksvig-Larsen, MD
principal investigator · Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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