Clinical trial NCT00991445: Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
Official title: Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Unicompartmental knee arthroplasty
Surgical exposure
Minimal invasive surgery
Local Infiltration Analgesia
Knee Arthroplasty
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to fulfilling discharge criteria
timeFrame: 0-2 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 0-3 months
measure: Hospital stay
timeFrame: 0-2 weeks
measure: Morphine consumption
timeFrame: 0-48 hours
measure: Knee function
timeFrame: 0-3 months
measure: Patient satisfaction
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Dept. of Orthopedic Surgery
Study officials:
affiliation: Region Örebro County
name: Kjell Axelsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Essving P, Axelsson K, Otterborg L, Spannar H, Gupta A, Magnuson A, Lundin A. Minimally invasive surgery did not improve outcome compared to conventional surgery following unicompartmental knee arthroplasty using local infiltration analgesia: a randomized controlled trial with 40 patients. Acta Orthop. 2012 Dec;83(6):634-41. doi: 10.3109/17453674.2012.736169. Epub 2012 Oct 8.