A Study on Knee Immobilization and Pain Levels After an Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Sponsor
LifeMark Health Research Group (Other)
Overall Status
Completed
CT.gov ID
NCT00338663
Collaborator
LifeMark Health (Other), Calgary Orthopaedic Research and Education Fund (Other)
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Study Details

Study Description

Brief Summary

The purpose of the study is to determine if there is difference in immediate postoperative pain levels (48 hours) between patients who wear a knee immobilizer splint compared to patients who do not wear a knee immobilizer splint after an anterior cruciate ligament reconstruction surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: knee immobilization splint
N/A

Detailed Description

This study will attempt to evaluate the efficacy of knee immobilization on patient postoperative pain levels following an ACL reconstruction. There is a lack of consensus in the area of postoperative knee bracing/immobilization. A survey of Canadian surgeons indicates that the primary reason for postoperative knee immobilization is to reduce pain. To the investigators' knowledge, there are no studies comparing the use of immediate (0-48 hours) postoperative knee immobilization versus no immobilization and pain control in this patient population.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial
Study Start Date :
May 1, 2006
Actual Study Completion Date :
Apr 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative. []

Secondary Outcome Measures

  1. Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative. []

  2. Analgesic type and time taken will be self reported by the patient at each VAS entry. []

  3. Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical: Patients' aged 18-40, ACL deficiency as determined by MRI or physical exam (positive lachmann and pivot shift tests) resulting in giving way episodes (acute or chronic) unresponsive to non-operative management and therefore requiring primary ACL reconstruction.

  • Arthroscopic: Concomitant meniscal resection.

Exclusion Criteria:
  • Clinical: Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy,) Concomitant lower extremity fracture, Ipsilateral collateral ligament injury within past 3 months, Time from ACL injury less than 6 weeks, Allergy/intolerance to Tylenol 3 with codeine and to Percocet, Third Party or Medical Legal.

  • Radiological: Skeletal immaturity (open growth plates).

  • Arthroscopic/surgical: Concomitant posterior cruciate ligament or collateral ligament repairs, Osteochondral lesions requiring microfracture, Meniscal repair, Patients not having both their semitendinosus and gracilis harvested.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banff Sport Medicine Clinic Banff Alberta Canada T1L 1B3
2 Lindsay Park Sports Injury Clinic Calgary Alberta Canada T2G 5B6

Sponsors and Collaborators

  • LifeMark Health Research Group
  • LifeMark Health
  • Calgary Orthopaedic Research and Education Fund

Investigators

  • Principal Investigator: Laurie A Hiemstra, MD, PhD, LifeMark Health Research Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00338663
Other Study ID Numbers:
  • E-20041
First Posted:
Jun 20, 2006
Last Update Posted:
Aug 23, 2007
Last Verified:
Aug 1, 2007

Study Results

No Results Posted as of Aug 23, 2007