Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT00991445|
Recruitment Status : Unknown
Verified October 2009 by Region Örebro County.
Recruitment status was: Recruiting
First Posted : October 8, 2009
Last Update Posted : October 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: Minimal Invasive Surgery Procedure: Conventional exposure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||September 2011|
Active Comparator: Group MIS
Minimal Invasive Surgery
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.
|Active Comparator: Conventional Exposure||
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.
- Time to fulfilling discharge criteria [ Time Frame: 0-2 weeks ]
- Pain intensity [ Time Frame: 0-3 months ]
- Hospital stay [ Time Frame: 0-2 weeks ]
- Morphine consumption [ Time Frame: 0-48 hours ]
- Knee function [ Time Frame: 0-3 months ]
- Patient satisfaction [ Time Frame: 0-3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991445
|Dept. of Orthopedic Surgery||Recruiting|
|Orebro, Sweden, SE-70185|
|Contact: Per Essving, MD +46196021000 firstname.lastname@example.org|
|Contact: Kjell Axelsson, Professor +46196021000 email@example.com|
|Principal Investigator: Kjell Axelsson, Professor|
|Principal Investigator:||Kjell Axelsson, Professor||Region Örebro County|