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

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ClinicalTrials.gov Identifier: NCT03198533
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker European Operations BV

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Device: Triathlon PA Device: Triathlon Pressfit Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit
Actual Study Start Date : July 10, 2007
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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
Implantation of Knee Prosthesis

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
Implantation of Knee Prosthesis




Primary Outcome Measures :
  1. Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 10 years follow-up ]
    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.


Secondary Outcome Measures :
  1. Investigation of clinical performance and patient outcome with the Knee Society Score (KSS) [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]
    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.

  2. Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]
    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).

  3. Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]
    The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

  4. Investigation of patient outcome with radiographic analysis [ Time Frame: 3 months, 1, 2, 5, 7 and 10 years ]
    Plain radiographs will be obtained for assessment of fixation of the device.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198533


Locations
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Sweden
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Skåne Län, Sweden, 281 38
Sponsors and Collaborators
Stryker European Operations BV
Investigators
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Principal Investigator: Sören Toksvig-Larsen, MD Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

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Responsible Party: Stryker European Operations BV
ClinicalTrials.gov Identifier: NCT03198533     History of Changes
Other Study ID Numbers: K-S-015 Triathlon RSA _3
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Keywords provided by Stryker European Operations BV:
Knee
Arthrosis
Implant