Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial

NCT ID: NCT00582517

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this project is to evaluate the effect of the Compass™ Universal Hinge external fixator on the outcome of patients following acute dislocation of the knee

Detailed Description

Prospective randomized outcome study. Patients will be randomized either into the control group (Group A) or the study group (Group B) based on a computer generated randomization table. Both groups will undergo an identical surgical protocol, as outlined below. The only difference is that patients in Group A will have a range of motion external brace placed following surgery, while patients in Group B will have a CKH placed. The rehabilitation protocol for the two groups will be identical, as outlined below. Both groups will undergo an Anterior Cruciate Ligament (ACL) reconstruction on a delayed basis two months following surgery, if the ACL was torn during the knee dislocation. The ACL reconstruction will be delayed in both groups if a minimum range of motion of 10-90 degrees has not been attained.

Surgical Protocol : Approximately 10 - 21 days following the injury, patients will undergo the first surgical procedure on their knee dislocation. During the first procedure, they will have a Posterior Cruciate Ligament (PCL) reconstruction using an achilles tendon allograft, with the direct onlay, two bundle technique. Additionally, any damage to either the posterior medial or posterior lateral corner will be repaired (not reconstructed), and any meniscus pathology will be addressed. The final step of this first procedure will be applying the CKH to patients randomized to the compass group (the alignment pins will be placed prior to repair of the corner). Patients will undergo an ACL reconstruction (if necessary) approximately 8 weeks following the initial surgery, when the CKH will be removed. Additional surgeries will be performed on patients to treat motion problems/arthrofibrosis as well as recurrent instability on an "as-needed basis."

Rehabilitation Protocol - aggressive rehabilitation will be started on the day following surgery. Patients will be placed in Continuous Passive Motion (CPM) machines with an initial range of motion of 0 - 30 degrees. The hinge will be locked into full extension for at least 4 hours per day. We will continue CPM for two weeks, with a goal of increasing by at least 10 degrees per day to 90 degrees of flexion. Weightbearing will be allowed as tolerated with the hinge locked in extension.

Conditions

Knee Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A External Brace

Group A will have a non-invasive range of motion external brace placed following surgery

Group Type: ACTIVE_COMPARATOR

Non-invasive External Knee Brace

Intervention Type: PROCEDURE

For Group A patients, an external knee brace (several brands available and no one brace specified for this study) will be placed on the leg following surgical repair of the knee dislocation.

Group B Compass Knee Hinge

Group B will have a Compass Knee Hinge placed

Group Type: EXPERIMENTAL

Compass Universal Hinge External Fixator

Intervention Type: DEVICE

Application of the Compass Knee Hinge adds approximately 30 minutes to the surgical time. After the apparatus has been in place for the appropriate amount of time (6-8 weeks), it is removed either in the clinical setting, or in the one-day surgery area of UAB Highlands.

Interventions

Compass Universal Hinge External Fixator

Application of the Compass Knee Hinge adds approximately 30 minutes to the surgical time. After the apparatus has been in place for the appropriate amount of time (6-8 weeks), it is removed either in the clinical setting, or in the one-day surgery area of UAB Highlands.

Intervention Type: DEVICE

Non-invasive External Knee Brace

For Group A patients, an external knee brace (several brands available and no one brace specified for this study) will be placed on the leg following surgical repair of the knee dislocation.

Intervention Type: PROCEDURE

Other Intervention Names

Compass Knee Hinge

Eligibility Criteria

Inclusion Criteria

• Trauma patient with a knee dislocation that requires surgical repair
• Adult patient (19 years and older)

Exclusion Criteria

• Patients unable or unwilling to comply with follow-up gait, radiographic and clinical evaluations necessary to complete the study
• Patients unable or unwilling to give informed consent and/or who have no responsible family member willing to give consent
• Pregnant women
• Prisoners

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Steven Theiss, MD

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Volgas, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, United States

Countries

United States

References

Stannard JP, Sheils TM, McGwin G, Volgas DA, Alonso JE. Use of a hinged external knee fixator after surgery for knee dislocation. Arthroscopy. 2003 Jul-Aug;19(6):626-31. doi: 10.1016/s0749-8063(03)00125-7.

Reference Type: RESULT

PMID: 12861201 (View on PubMed)

Other Identifiers

OGCA Contract #200497

Identifier Type: OTHER

Identifier Source: secondary_id

F000330008

Identifier Type: -

Identifier Source: org_study_id