Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

NCT02203045 | Completed

• 1 other identifier: 12-0648
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.

Conditions

Osteoarthritis

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Quadriceps Muscle Force

  NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA

  Pre-operative, 3 weeks and 3 months post-operative

Secondary Outcomes (4)

• Change from Baseline in Balance testing

  Pre-operatively, 3 weeks and 3 months post-operative

• Change from Baseline in Isometric Hamstring Strength

  Pre-operatively, 3 weeks and 3 months post-operative

• Change from Baseline from Voluntary Quadriceps Activation

  Pre-operative, 3 weeks and 3 months post-operative

• Change from Baseline in Range of Motion

  Pre-operatively, 3 weeks and 3 months post-operatively

Other Outcomes (5)

• Radiographic Examination

  1 to 2 months post surgery

• Deep Vein Thrombosis Formation

  48- 72 hours post operative

• Postoperative blood loss

  48 hours post surgery

Study Arms (2)

Tourniquet

ACTIVE COMPARATOR

All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (\>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.

Other: Total Knee Arthroplasty

Non- tourniquet

EXPERIMENTAL

All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (\>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.

Other: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty OTHER

Non- tourniquet; Tourniquet

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis

You may not qualify if:

• no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Joint Replacement: collaborator
• CommonSpirit Health: collaborator

Study Sites (2)

Univeristy of Colorado

Aurora, Colorado, 80045, United States

Location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Douglas Dennis, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

• Jennifer Stevens-Lapsley, MPT and PhD

  University of Colorado, Denver

  STUDY DIRECTOR

• Ray Kim, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2014-10

Locations

US (2)