Clinical trial NCT00338663: A Study on Knee Immobilization and Pain Levels After an Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Official title: The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: anterior cruciate ligament reconstruction
knee immobilization
postoperative pain
Lead sponsor: LifeMark Health Research Group
Sponsor class: OTHER
Collaborators: name: LifeMark Health
name: Calgary Orthopaedic Research and Education Fund
First posted: 2006-06-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative.
Secondary outcomes:
measure: Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative.
measure: Analgesic type and time taken will be self reported by the patient at each VAS entry.
measure: Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon.
Other outcomes:
Locations:
city: Banff
country: Canada
facility: Banff Sport Medicine Clinic
state: Alberta
city: Calgary
country: Canada
facility: Lindsay Park Sports Injury Clinic
state: Alberta
Study officials:
affiliation: LifeMark Health Research Group
name: Laurie A Hiemstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: