Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

NCT00436982 | Completed Results

• 2 other identifiers: K-S-015 Triathlon RSA_1K-S-015_1
• 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)

• Roentgen Stereophotogrammetric Analysis (RSA)

  To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.

  2 years

Secondary Outcomes (7)

• Roentgen Stereophotogrammetric Analysis (RSA)

  3 months, 1, 5, 7 and 10 years

• Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)

  [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]

• Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire

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

• Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire

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

• Mean Operative Time

  intra-operative

Study Arms (2)

Cemented Triathlon total knee system

ACTIVE COMPARATOR

The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.

Device: Cemented Triathlon total knee system

Cemented Duracon total knee system

ACTIVE COMPARATOR

The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.

Device: Duracon total knee system

Interventions

Cemented Triathlon total knee system DEVICE

Orthopaedic implant

Cemented Triathlon total knee system

Duracon total knee system DEVICE

Orthopaedic implant

Cemented Duracon total knee system

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 (OA), Stage II-V \[Ahlbäck, 1968\] 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)

Hässleholm Hospital

Hässleholm, Sweden

Location

Related Publications (2)

• Molt M, Ljung P, Toksvig-Larsen S. Does a new knee design perform as well as the design it replaces? Bone Joint Res. 2012 Dec 1;1(12):315-23. doi: 10.1302/2046-3758.112.2000064. Print 2012 Dec.

  PMID: 23610663 RESULT

• Molt M, Toksvig-Larsen S. Similar early migration when comparing CR and PS in Triathlon TKA: A prospective randomised RSA trial. Knee. 2014 Oct;21(5):949-54. doi: 10.1016/j.knee.2014.05.012. Epub 2014 Jun 7.

  PMID: 24974301 DERIVED

Results Point of Contact

• Title: Eric Garling, PhD, Snr. Director Medical & Scientific Affairs Europe
• Organization: Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands

Eric.Garling@stryker.com

+31 20 219 2660

Study Officials

• Sören Toksvig-Larsen, ass. prof

  Department of ortopaedics, Hässleholm Hospital

  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: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: January 4, 2017
• Last Updated: February 22, 2024
• Results First Posted: December 8, 2015

Record last verified: 2024-02

Locations

SE (1)