Clinical trial NCT00436982: Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
Official title: Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.

Eligibility criteria: Inclusion Criteria:

1. Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] 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).

Primary outcomes:
measure: Roentgen Stereophotogrammetric Analysis (RSA)
timeFrame: 2 years
Secondary outcomes:
measure: Roentgen Stereophotogrammetric Analysis (RSA)
timeFrame: 3 months, 1, 5, 7 and 10 years
measure: Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
timeFrame: [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]
measure: Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
timeFrame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
measure: Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire
timeFrame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
measure: Mean Operative Time
timeFrame: intra-operative
measure: Duration Hospital Stay
timeFrame: preoperative to discharge
measure: Blood Loss
timeFrame: intra-operative
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Hässleholm Hospital
Study officials:
affiliation: Department of ortopaedics, Hässleholm Hospital
name: Sören Toksvig-Larsen, ass. prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.