Clinical trial NCT02739035: MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Official title: Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stiffness Following Total Knee Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Knee Society
First posted: 2016-04-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone.

Outcomes will include pain, range of motion, as well as subjective outcome scores.

Detailed description: Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
2. MUA's scheduled between 6-10 weeks postoperatively

Exclusion Criteria:

1. Intolerance to NSAIDs
2. Renal dysfunction
3. Age \< 18 or \> 90 years
4. Primary diagnosis of rheumatoid arthritis
5. Patients with a Glomerular Filtration Rate (GFR) \<60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)

Primary outcomes:
measure: Knee Range of Motion After Manipulation Under Anesthesia
timeFrame: 6 weeks after manipulation
measure: Knee Range of Motion After Manipulation Under Anesthesia
timeFrame: 1 year from the date of the manipulation
Secondary outcomes:
measure: Knee Society Functional Score
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: Knee Society Knee Score
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: Short Form Survey 12-item Version 2 (SF-12v2): Physical Health
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: Short Form Survey 12-item Version 2 (SF-12v2): Mental Health
timeFrame: 6 weeks after MUA, 1 Year after MUA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score
timeFrame: 6 weeks after MUA, 1 year after MUA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score
timeFrame: 6 weeks after MUA, 1 year after MUA
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life
timeFrame: 6 weeks after MUA, 1 year after MUA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: PROMIS-29 Outcome Form: Physical Function
timeFrame: 6 weeks after the MUA, and 1 year after the MUA
measure: PROMIS-29 Outcome Form: Anxiety
timeFrame: 6 weeks after MUA, and 1 year after MUA
measure: PROMIS-29 Outcome Form: Depression
timeFrame: 6 weeks after MUA, and 1 year after MUA
measure: PROMIS-29 Outcome Form: Fatigue
timeFrame: 6 weeks after MUA, and 1 year after MUA
measure: PROMIS-29 Outcome Form: Sleep Disturbance
timeFrame: 6 weeks after MUA, and 1 year after MUA
measure: PROMIS-29 Outcome Form: Social Activities
timeFrame: 6 weeks after MUA, and 1 year after MUA
measure: PROMIS-29 Outcome Form: Pain Interference
timeFrame: 6 weeks after MUA, 1 year after MUA
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: HipKnee Arkansas Foundation
state: Arkansas
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: New York - Presbyterian at Columbia University
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Ceter, Dept. of Orthopaedics
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Lansdale
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Aria 3B Orthopaedic Specialists
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: Mayo Clinic
name: Abdel Matthew, M.D.
role: PRINCIPAL_INVESTIGATOR
References: