Clinical trial NCT02525601: Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented
Official title: Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining (CR) - Cemented vs. Uncemented
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2015-08-17
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 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 CR cemented vs. uncemented.

Eligibility criteria: Inclusion Criteria:

1. Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck Trauma Score, 1968 391\] 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).

Primary outcomes:
measure: Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
timeFrame: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes
Secondary outcomes:
measure: Investigation of patient outcome with radiographic analysis
timeFrame: 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
measure: Investigation of clinical performance and patient outcome with Knee Society Score (KSS)
timeFrame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
measure: Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
timeFrame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
measure: Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
timeFrame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
state: Skåne Län
Study officials:
affiliation: Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
name: Sören Toksvig-Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References: