Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet

NCT01309035 | Completed DMC

• 1 other identifier: ON-001-AE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate dissections in a bloodless operative field. A tourniquet can be defined as a constricting or compressing device used to control temporarily venous and arterial circulation to an extremity. Pressure is applied circumferentially on the skin and underlying tissues of a limb. This pressure is transferred to the walls of vessels, causing them to become occluded. It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a number of disadvantages, for instance, severe pain and muscle effects during the first postoperative day, thereby slowing rehabilitation. Other side effects related to tourniquet use, include pulmonary embolus caused by venous thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque. Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome, post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since the introduction of modern cementing techniques, no previous clinical studies have investigated the advantages or disadvantages of tourniquet use in knee replacement surgery. Aims/hypothesis of the study:

1. 1.To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.
2. 2.To study whether use of a tourniquet affects leg muscles during and after surgery, as measured by with use of microdialysis to quantify level of ischemia .
3. 3.To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, the investigators do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.

Conditions

Arthropathy of Knee Joint

Keywords

Prothesis fixation; Bloodlessness

Outcome Measures

Primary Outcomes (1)

• Determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use.

  To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, we do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.

  1.Feb 2011 -1 jan 2013

Secondary Outcomes (1)

• To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.

  1.feb 2011 - 1.jan 2013

Study Arms (2)

With Tourniquet

ACTIVE COMPARATOR

Total Knee Arthroplasty. Surgery performed during use of a tourniquet.

Procedure: Total Knee Arthroplasty

Without Tourniquet

EXPERIMENTAL

Total Knee Arthroplasty. Surgery performed without use of a tourniquet.

Procedure: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

Surgery for OA knee pains

With Tourniquet; Without Tourniquet

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKR)
• Age 50 and above (not older than 85)
• BMI \< 35 and height \>160 cm
• No severe cardiovascular conditions
• No previously knee surgery done in the same knee
• Oral and written acceptance

You may not qualify if:

• Severe obesity
• rheumatic diseases
• Absence of pulse in foot
• Diabetes
• Previous operation in concerning knee
• Lack of informed consent or ability to read / understand Danish

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Aalborg University Hospital, Northern Orthopaedic Division, Department of Arthroplasty, Farsoe Clinic

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: March 4, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

DK (1)