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

Sponsors and Collaborators:	LifeMark Health Research Group LifeMark Health Management Inc. Calgary Orthopaedic Research and Education Fund (COREF)
Information provided by:	LifeMark Health Research Group
ClinicalTrials.gov Identifier:	NCT00338663

Purpose

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	Intervention
Anterior Cruciate Ligament Reconstruction	Device: knee immobilization splint

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial

Further study details as provided by LifeMark Health Research Group:

Primary Outcome Measures:

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:

Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative.
Analgesic type and time taken will be self reported by the patient at each VAS entry.
Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon.

Estimated Enrollment:	88
Study Start Date:	May 2006
Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338663

Locations

Canada, Alberta
Banff Sport Medicine Clinic
Banff, Alberta, Canada, T1L 1B3
Lindsay Park Sports Injury Clinic
Calgary, Alberta, Canada, T2G 5B6

Sponsors and Collaborators

LifeMark Health Research Group

LifeMark Health Management Inc.

Calgary Orthopaedic Research and Education Fund (COREF)

Investigators

Principal Investigator:

Laurie A Hiemstra, MD, PhD

LifeMark Health Research Group

More Information

Study ID Numbers:	E-20041
Study First Received:	June 16, 2006
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00338663
Health Authority:	Canada: Ethics Review Committee

Keywords provided by LifeMark Health Research Group:

anterior cruciate ligament reconstruction
knee immobilization
postoperative pain

Study placed in the following topic categories:

Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on January 14, 2009