NCT00991445

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2009

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

October 7, 2009

Last Update Submit

October 7, 2009

Conditions

Knee Osteoarthritis

Keywords

Unicompartmental knee arthroplastySurgical exposureMinimal invasive surgeryLocal Infiltration AnalgesiaKnee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Time to fulfilling discharge criteria

    0-2 weeks

Secondary Outcomes (5)

  • Pain intensity

    0-3 months

  • Hospital stay

    0-2 weeks

  • Morphine consumption

    0-48 hours

  • Knee function

    0-3 months

  • Patient satisfaction

    0-3 months

Study Arms (2)

Group MIS

ACTIVE COMPARATOR

Minimal Invasive Surgery

Procedure: Minimal Invasive Surgery

Conventional Exposure

ACTIVE COMPARATOR
Procedure: Conventional exposure

Interventions

Minimal Invasive SurgeryPROCEDURE

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.

Group MIS
Conventional exposurePROCEDURE

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.

Conventional Exposure

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for unicompartmental knee arthroplasty
  • Aged 20-80 yrs
  • ASA physical status I-III and mobility indicating normal postoperative mobilization

You may not qualify if:

  • Known allergy or intolerance to local anesthetics, ASA or NSAID
  • Serious liver-, heart- or renal decease
  • Rheumatoid arthritis
  • Chronic pain or bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Orthopedic Surgery

Örebro, Örebro County, SE-70185, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23043272DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjell Axelsson, Professor

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

September 1, 2011

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

SE(1)