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

NCT00338663 | Completed DMC

• 1 other identifier: E-20041
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

anterior cruciate ligament reconstruction; knee immobilization; postoperative pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Interventions

knee immobilization splint DEVICE

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• LifeMark Health Research Group: lead
• LifeMark Health: collaborator
• Calgary Orthopaedic Research and Education Fund: collaborator

Study Sites (2)

Banff Sport Medicine Clinic

Banff, Alberta, T1L 1B3, Canada

Location

Lindsay Park Sports Injury Clinic

Calgary, Alberta, T2G 5B6, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Laurie A Hiemstra, MD, PhD

  LifeMark Health Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: May 1, 2006
• Study Completion: April 1, 2007
• Last Updated: August 23, 2007

Record last verified: 2007-08

Locations

CA (2)