Comparison of Three Knee Replacements

Coxa, Hospital for Joint Replacement

Status: Unknown

Conditions: Arthroplasty; Osteoarthritis, Knee; Total Knee Replacement

Treatments: Device: NexGen; Device: Persona; Device: PFC

Study type: Interventional

Funder types: Other

Identifiers

NCT03339557

R15053

Details and patient eligibility

About

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).

Full 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).

Enrollment: 240 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 3 patient groups

PFC Total Knee Replacement

Active Comparator group

Description:

PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.

Treatment:

Device: Persona

Device: NexGen

NexGen Total Knee Replacement

Active Comparator group

Description:

NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.

Treatment:

Device: Persona

Device: PFC

Persona Total Knee Replacement

Active Comparator group

Description:

Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.

Treatment:

Device: NexGen

Device: PFC