Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty

C

Colorado Joint Replacement

Status

Completed

Conditions

Osteoarthritis
Bilateral Total Knee Arthroplasty

Treatments

Procedure: No Drain
Procedure: Drain

Study type

Interventional

Funder types

Other

Identifiers

NCT02693457
1541

Details and patient eligibility

About

This randomized controlled trial is designed to determine the effect of suction drain usage on the reduction of postoperative swelling following total knee replacement. Furthermore, this study will determine the relationship between postoperative swelling and quadriceps muscle function. This study will be performed in a cohort of patients undergoing bilateral total knee replacement and the suction intra-articular drain will be randomized to one of the two operative knees prior to surgery.

Full description

This study has two primary aims: 1) to determine the effects of intra-articular suction drain use, placed during total knee arthroplasty (TKA), on postoperative knee joint effusion, which is the collection of fluid in the joint capsule, and lower extremity swelling compared to a TKA without the use of an intra-articular drain and, 2) to describe the relationship between postoperative lower extremity swelling and quadriceps function (strength and activation). The use of intra-articular drains during TKA surgery has been highly disputed, due to the fear of increasing risk of infection from a secondary incision site, however, past studies have found no increased risk of complication from drain use. Furthermore, studies have shown that drain use may reduce the amount of hidden blood loss, or blood that is collected in the intra-articular space. Of interest, effusion may be associated with decreased quadriceps function. Previous research examining the influence of knee effusion on quadriceps function has shown that with laboratory-induced acute knee effusion, quadriceps activation and force production are reduced. However, previous findings lack the ability to inform care for patients following TKA due to the acute nature of the effusion and the inability to translate findings from healthy individuals to a clinical population. This study has the potential to greatly improve care for patients undergoing TKA by informing the surgical procedure while also providing important evidence for the influence of postoperative swelling on quadriceps muscle function. In order to maintain patient blinding, a non-functional subcutaneous drain will be placed in the non-randomized knee. Patients will be blinded to any fluid output from the intra-articular drain. A medial parapatellar approach will be utilized for exposure of the knee. All TKAs will be performed using a gap balancing technique with substitution of the posterior collateral ligament (PCL). In all cases, a tensioning device will be used to establish balanced, symmetrical flexion and extension spaces. All TKA procedures will utilize cemented implants. Randomly assigned drains (intra-articular or subcutaneous) will be placed in respective knees before closure. All patients will be treated with Tranexamic Acid intravenously to standardize blood loss and effusion. All patients will be provided standard rehabilitation protocol during their inpatient stay. After hospital discharge, patients will be encouraged to receive outpatient physical therapy 2-3 times per week for 6 weeks.

Enrollment

29 patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≤ 70 years
  • Undergoing bilateral, simultaneous, primary knee replacements

Exclusion criteria

  • neurological, vascular or cardiac problems that limit function
  • unstable orthopedic conditions that limit functional performance
  • previous history of inflammatory arthritis or other inflammatory systemic conditions
  • previous history of deep vein thrombosis in either lower extremity
  • lymphedema or other conditions that lead to lower extremity edema that may influence the outcomes of the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

29 participants in 2 patient groups

Drain
Active Comparator group
Description:
Intra-articular drain will be placed at closure of randomized knee for 24 hours
Treatment:
Procedure: Drain
No Drain
Experimental group
Description:
No intra-articular will be placed in the contralateral knee of the same patient. A placebo drain will be placed so patient is unaware of which knee contains working drain.
Treatment:
Procedure: No Drain

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems