Home
Clinical Trials
Comparison of Three Knee Repl...

Comparison of Three Knee Replacements

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen

NCT03073941

Osteoarthritis, Knee

ACTIVE_NOT_RECRUITING NA

A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

NCT02494544

Osteoarthritis

TERMINATED NA

Cemented vs Cementless Persona Keel RCT

NCT05630053

Knee Pain Chronic Rheumatoid Arthritis Osteoarthritis +6 more

ACTIVE_NOT_RECRUITING NA

Persona MC vs Attune Total Knee Replacement Study

NCT03580772

Knee Osteoarthritis

TERMINATED

Persona Versus NexGen

NCT02269254

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee Arthroplasty Total Knee Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients will be operated upon using the implant allocated in randomization. Participants are blinded to the implant design used for their operation. Staff at the ward is also blinded. And the physiotherapists conducting the follow-up visits (at 2-3 months, 1 year and 2 years, i.e. the outcome assessors) are also blinded to the allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PFC Total Knee Replacement

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

Group Type ACTIVE_COMPARATOR