Clinical trial NCT03339557: Comparison of Three Knee Replacements
Official title: Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Arthroplasty
Total Knee Replacement
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be recruited from Coxa outpatient clinic according to inclusion and exclusion criteria. The participating orthopedic surgeons will recruit patients along their out-patient work. The indications for the surgical treatment in the study will follow the routine clinical guidelines of the hospital. When TKR surgery is decided, the eligible patients will be informed and those willing to participate will be randomized into one of the three implant groups.
Primary purpose: TREATMENT

Brief summary: The present randomized controlled trial is designed to compare one novel total knee replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).

Detailed description: The study will compare the short-term functional outcome (at 2 years) of TKR performed with a novel TKR design (Persona , Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC, DePuy, Warsaw, IN, USA and Nexgen, Zimmer, Warsaw, IN, USA).

Eligibility criteria: Inclusion Criteria:

* patients undergoing total knee replacement surgery for primary osteoarthritis
* no previous open major surgery in the joint ( e.g. osteotomy)
* unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future
* patients living in the local hospital district (Pirkanmaa Hospital District)
* Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs

Exclusion Criteria:

* Unwilling to provide informed consent
* \> 15 degrees varus or valgus, or \>15 degree fixed flexion deformity
* predominantly patellofemoral osteoarthritis
* Physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)

Primary outcomes:
measure: Changes in patient reported outcome measures scores (PROMs), Functional improvement
timeFrame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary outcomes:
measure: Changes in PROMs, Functional improvement
timeFrame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
measure: Changes in health-related quality of life (HRQoL)
timeFrame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
measure: Changes in activity rating scale
timeFrame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
measure: Changes in pain scale measurement
timeFrame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Coxa, Hospital for Joint Replacement
state: Pirkanmaa
Study officials:
affiliation: Coxa, Hospital for Joint Replacement
name: Tero Irmola, MD
role: PRINCIPAL_INVESTIGATOR
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