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Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Hospital Orebro.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00991445
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 7, 2009
October 7, 2009
May 2009
May 2011   (final data collection date for primary outcome measure)
Time to fulfilling discharge criteria [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Pain intensity [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
  • Morphine consumption [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Knee function [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
  • 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.
  • Procedure: 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.
  • Active Comparator: Group MIS
    Minimal Invasive Surgery
    Intervention: Procedure: Minimal Invasive Surgery
  • Active Comparator: Conventional Exposure
    Intervention: Procedure: Conventional exposure
Essving P, Axelsson K, Otterborg L, Spännar 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Sweden
 
NCT00991445
RAK-Incision
Yes
Professor Kjell Axelsson, University Hospital Orebro
University Hospital Orebro
Not Provided
Principal Investigator: Kjell Axelsson, Professor University Hospital Orebro
University Hospital Orebro
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP