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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338663
• Other study ID #: E-20041
• Status: Completed
• Phase: N/A
• First received: June 16, 2006
• Last updated: August 22, 2007
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2007
• Source: LifeMark Health Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• knee immobilization splint

Locations

Country	Name	City	State
Canada	Banff Sport Medicine Clinic	Banff	Alberta
Canada	Lindsay Park Sports Injury Clinic	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
LifeMark Health Research Group	Calgary Orthopaedic Research and Education Fund, LifeMark Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative.
Secondary	Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative.
Secondary	Analgesic type and time taken will be self reported by the patient at each VAS entry.
Secondary	Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon.