Clinical trial NCT02535741: Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee
Official title: Clinical Outcome Study for the Triathlon CR Total Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Knee Replacement
Arthroplasty
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 168
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.

Detailed description: An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.

Eligibility criteria: Inclusion Criteria:

1. Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
2. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
3. Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
4. Patients requiring a primary total knee replacement.
5. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
6. Patients with intact collateral ligaments.

Exclusion Criteria:

1. Patients with inflammatory arthritis.
2. Patients that are morbidly obese, body mass index (BMI) \> 40.
3. Patients with a history of total / unicompartmental reconstruction of the affected joint.
4. Patients that have had a high tibial osteotomy or femoral osteotomy.
5. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
6. Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
7. Patients that are immunologically compromised, or receiving chronic steroids (\>30 days duration).
8. Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
9. Patients with a knee fusion to the affected joint.
10. Patients with an active or suspected latent infection in or about the knee joint.
11. Patients with a history of total joint replacement on the opposite knee within less than 1 year.
12. Patients requiring bilateral total knee replacement.

Primary outcomes:
measure: Mean Triathlon CR Active Range of Motion (ROM)
timeFrame: 2 years follow-up
Secondary outcomes:
measure: Investigation of Patient Outcome With Radiographic Analysis
timeFrame: Pre-operative, 3 months, 1, 2 and 5 years follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
timeFrame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire
timeFrame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire
timeFrame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: Koge Sygehus
state: Roskilde
city: Turku
country: Finland
facility: Hospital District of South West Finland
state: Westfinland
city: Baden-Baden
country: Germany
facility: DRK Klinik Baden-Baden
state: Baden-Württemberg
city: Hannover
country: Germany
facility: Medizinische Universität Hannover
state: Niedersachsen
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Andalusia
city: Barcelona
country: Spain
facility: Instituto Municipal de Asistencia Sanitaria
Study officials:
affiliation: Medizinische Universität Hannover
name: Christina Stukenborg-Colsman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.