Feasibility study to evaluate the clinical outcome of the Scorpio knee prosthesis following THE LAZIRUSH CONCEPT

Feasibility study to evaluate the clinical outcome of the Scorpio knee prosthesis following THE LAZIRUSH CONCEPT - Lazirush study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34366

Enrollment

Registered

2011-04-07

Start date

2011-05-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee arthrosis

Interventions

All patients will get a total knee replacement surgery using the lazirush concept or the concept of joint care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: A.Patients willing to sign the EC approved, study specific Informed Patient Consent Form. B.Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation. C.Patients requiring a primary unilateral total knee replacement. D.Patients with ASA Physical status 1 &2. E. Patients having a partner at home for assistence.

Exclusion criteria

Exclusion criteria: A.Patients with Rheumatoid arthritis, insulin dependent diabetes, severe osteoporosis, or an inflammatory cause for osteoarthritis. B.Patients with other lower limb problems than their planned primary unilateral total knee arthroplasty. C.Patients requiring revision knee surgery. D.Patients with ASA physical status more than 2. E.Patients requiring bilateral total knee replacement

Design outcomes

Primary

Measure	Time frame
To evaluate the early and late postoperative results measured by the KSS and ROM of the Scorpio knee prosthesis following the Lazirush concept and compare this with a matched group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept.	—

Secondary

Measure	Time frame
To evaluate the early and late postoperative results concerning the incidence and type of postoperative complications, duration of hospital stay, use of pain medication, need for blood transfusion, HB level, drain production, operation parameters, knee swelling, KOOS, Straight leg raise, ambulatory status, single leg stance, ability to walk stairs, X-ray parameters, patient satisfaction, need for home care, resumption of work, chair rise ability, walking speed, amount of pain during rest and activity, and economical costs of the Scorpio knee prosthesis following the Lazirush concept and compare this with a matched group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept.	—

Measure

Time frame

To evaluate the early and late postoperative results concerning the incidence and type of postoperative complications, duration of hospital stay, use of pain medication, need for blood transfusion, HB level, drain production, operation parameters, knee swelling, KOOS, Straight leg raise, ambulatory status, single leg stance, ability to walk stairs, X-ray parameters, patient satisfaction, need for home care, resumption of work, chair rise ability, walking speed, amount of pain during rest and activity, and economical costs of the Scorpio knee prosthesis following the Lazirush concept and compare this with a matched group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)