Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS

NCT02522728 | Completed Results

• 1 other identifier: K-S-015 Triathlon RSA _2
• Study Type: interventional
• Target: 58
• 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; Arthroplasty; Implant

Outcome Measures

Primary Outcomes (1)

• Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)

  Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.

  2 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

  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 CR

ACTIVE COMPARATOR

Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.

Device: Triathlon CR

Triathlon PS

ACTIVE COMPARATOR

Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.

Device: Triathlon PS

Interventions

Triathlon CR DEVICE

Implantation of Knee Prosthesis

Triathlon CR

Triathlon PS DEVICE

Implantation of Knee Prosthesis

Triathlon PS

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 \[Ahlbäck, 1968 391\] 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

Results Point of Contact

• Title: Eric Garling, PhD Snr. Director Medical & Scientific Affairs Europe
• Organization: Stryker Orthopaedics

Eric.Garling@stryker.com

+31 6 467 135 18

Study Officials

• Sören Toksvig-Larsen, MD

  Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 13, 2015
• Study Start: January 23, 2007
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: February 22, 2024
• Results First Posted: August 2, 2019

Record last verified: 2024-02

Locations

SE (1)