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

NCT03198533 | Completed

• 1 other identifier: K-S-015 Triathlon RSA _3
• 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

Keywords

Knee; Arthrosis; Implant

Outcome Measures

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.

  10 years follow-up

Secondary Outcomes (4)

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

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

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

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

• Investigation of patient outcome with radiographic analysis

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

Study Arms (2)

Triathlon PA

ACTIVE COMPARATOR

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

Triathlon Pressfit

ACTIVE COMPARATOR

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

Triathlon PA DEVICE

Implantation of Knee Prosthesis

Triathlon PA

Triathlon Pressfit DEVICE

Implantation of Knee Prosthesis

Triathlon Pressfit

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 \[Ahlbäck, 1968 391\] 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

• Stryker Orthopaedics: lead

Study Sites (1)

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Hässleholm, Skåne County, 281 38, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sören Toksvig-Larsen, MD

  Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 26, 2017
• Study Start: July 10, 2007
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

SE (1)