Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

October 7, 2009 updated by: Region Örebro County

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Orebro, Sweden, SE-70185
        • Recruiting
        • Dept. of Orthopedic Surgery
        • Principal Investigator:
          • Kjell Axelsson, Professor
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to fulfilling discharge criteria
Time Frame: 0-2 weeks
0-2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity
Time Frame: 0-3 months
0-3 months
Knee function
Time Frame: 0-3 months
0-3 months
Hospital stay
Time Frame: 0-2 weeks
0-2 weeks
Patient satisfaction
Time Frame: 0-3 months
0-3 months
Morphine consumption
Time Frame: 0-48 hours
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Investigators

  • Principal Investigator: Kjell Axelsson, Professor, Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 8, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAK-Incision

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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