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
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Procedure: Minimal Invasive Surgery
Procedure: Conventional exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • Time to fulfilling discharge criteria [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991445

Locations
Sweden
Dept. of Orthopedic Surgery Recruiting
Orebro, Sweden, SE-70185
Contact: Per Essving, MD    +46196021000    per.essving@orebroll.se   
Contact: Kjell Axelsson, Professor    +46196021000    kjell.axelsson@orebroll.se   
Principal Investigator: Kjell Axelsson, Professor         
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Kjell Axelsson, Professor University Hospital Orebro
  More Information

No publications provided by University Hospital Orebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Kjell Axelsson, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00991445     History of Changes
Other Study ID Numbers: RAK-Incision
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital Orebro:
Unicompartmental knee arthroplasty
Surgical exposure
Minimal invasive surgery
Local Infiltration Analgesia
Knee Arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 18, 2014