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Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Minimal Invasive Surgery
Conventional exposure
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Unicompartmental knee arthroplasty, Surgical exposure, Minimal invasive surgery, Local Infiltration Analgesia, Knee Arthroplasty

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Orthopedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group MIS

Conventional Exposure

Arm Description

Minimal Invasive Surgery

Outcomes

Primary Outcome Measures

Time to fulfilling discharge criteria

Secondary Outcome Measures

Pain intensity
Hospital stay
Morphine consumption
Knee function
Patient satisfaction

Full Information

First Posted
October 7, 2009
Last Updated
October 7, 2009
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT00991445
Brief Title
Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty
Official Title
Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Region Örebro County

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Unicompartmental knee arthroplasty, Surgical exposure, Minimal invasive surgery, Local Infiltration Analgesia, Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group MIS
Arm Type
Active Comparator
Arm Description
Minimal Invasive Surgery
Arm Title
Conventional Exposure
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Minimal Invasive Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to fulfilling discharge criteria
Time Frame
0-2 weeks
Secondary Outcome Measure Information:
Title
Pain intensity
Time Frame
0-3 months
Title
Hospital stay
Time Frame
0-2 weeks
Title
Morphine consumption
Time Frame
0-48 hours
Title
Knee function
Time Frame
0-3 months
Title
Patient satisfaction
Time Frame
0-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Professor
Organizational Affiliation
Region Örebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Orthopedic Surgery
City
Orebro
ZIP/Postal Code
SE-70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Essving, MD
Phone
+46196021000
Email
per.essving@orebroll.se
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Professor
Phone
+46196021000
Email
kjell.axelsson@orebroll.se
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
23043272
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.
Results Reference
derived

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Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

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