Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00991445
• Other study ID #: RAK-Incision
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2009
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.

Description:

Postoperative pain is often moderate to severe following unicompartmental knee arthroplasty. In order to reduce postoperative pain and improve mobilization the minimal invasive technique was developed. After a 8-10 cm skin incision, a medial parapatellar capsule incision in made. The rectus tendon or the vastus medialis are not incised and the patella is not everted.

In recent years The Local Infiltration Analgesia (LIA) technique has been developed to reduce postoperative pain. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The aim of this study is to investigate if Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for unicompartmental knee arthroplasty

• Aged 20-80 yrs

• ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria:

• Known allergy or intolerance to local anesthetics, ASA or NSAID

• Serious liver-, heart- or renal decease

• Rheumatoid arthritis

• Chronic pain or bleeding disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Minimal Invasive Surgery
After a 8-10 cm skin incision, a medial parapatellar capsule incision is made. The vastus medialis muscle or the rectus tendon are not incised, nor is the patella everted. The patella is merely pushed slightly aside when the bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.
• Conventional exposure
After a 15-20 cm midline skin incision is made, a medial parapatellar capsule incision is made. The incision is carried up through the insertion of the vastus medialis and into the rectus tendon. The patella is everted. The bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.

Locations

Country	Name	City	State
Sweden	Dept. of Orthopedic Surgery	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to fulfilling discharge criteria		0-2 weeks	No
Secondary	Pain intensity		0-3 months	No
Secondary	Hospital stay		0-2 weeks	No
Secondary	Morphine consumption		0-48 hours	No
Secondary	Knee function		0-3 months	No
Secondary	Patient satisfaction		0-3 months	No