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

NCT02693457 | Completed

• 1 other identifier: 1541
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Bilateral Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Isomechanical Dynomometery

  Knee Extensor Strength

  2 Weeks Post-Operative

Secondary Outcomes (51)

• Lower Extremity Isomechanical Dynomometery

  Pre-Operative

• Lower Extremity Hand Held Dyanmometry

  48 hours Post-Operative

• Lower Extremity Isomechanical Dynomometery

  6 Weeks Post-Operative

• Lower Extremity Isomechanical Dynomometery

  3 Month Post-Operative

• Clinical Quadriceps Activation Battery

  Pre-Operative

Study Arms (2)

Drain

ACTIVE COMPARATOR

Intra-articular drain will be placed at closure of randomized knee for 24 hours

Procedure: Drain

No Drain

EXPERIMENTAL

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.

Procedure: No Drain

Interventions

Drain PROCEDURE

One randomized knee will be assigned to receive an intra-articular drain procedure following bilateral total knee arthroplasty. The drain will be removed 24 hours post-operatively. The patient will be blinded to fluid output from intra-articular drain.

Drain

No Drain PROCEDURE

The contralateral knee will be assigned to a placebo drain procedure following bilateral total knee arthroplasty. This will blind the patient as to which knee contains the functioning intra-articular drain. A non-suction/ non-functional subcutaneous drain will act as the placebo drain. This drain will not output any fluid and will also be removed 24 hours after post-operatively.

No Drain

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Related Publications (4)

• Esler CN, Blakeway C, Fiddian NJ. The use of a closed-suction drain in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 2003 Mar;85(2):215-7. doi: 10.1302/0301-620x.85b2.13357.

  PMID: 12678355 BACKGROUND

• Holt BT, Parks NL, Engh GA, Lawrence JM. Comparison of closed-suction drainage and no drainage after primary total knee arthroplasty. Orthopedics. 1997 Dec;20(12):1121-4; discussion 1124-5. doi: 10.3928/0147-7447-19971201-05.

  PMID: 9415907 BACKGROUND

• Palmieri-Smith RM, Villwock M, Downie B, Hecht G, Zernicke R. Pain and effusion and quadriceps activation and strength. J Athl Train. 2013 Mar-Apr;48(2):186-91. doi: 10.4085/1062-6050-48.2.10. Epub 2013 Feb 20.

  PMID: 23672382 BACKGROUND

• Pietrosimone B, Lepley AS, Murray AM, Thomas AC, Bahhur NO, Schwartz TA. Changes in voluntary quadriceps activation predict changes in muscle strength and gait biomechanics following knee joint effusion. Clin Biomech (Bristol). 2014 Sep;29(8):923-9. doi: 10.1016/j.clinbiomech.2014.06.014. Epub 2014 Jul 4.

  PMID: 25062605 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Drainage

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Jason Jennings, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopedic Surgeon

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)