MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty

NCT ID: NCT02739035

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Stiffness Following Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MUA alone

Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MUA with dexamethasone and celecoxib

For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

8 mg of IV dexamethasone immediately before MUA.

Celecoxib

Intervention Type: DRUG

2 weeks per mouth of celecoxib (200 mg daily)

Interventions

Dexamethasone

8 mg of IV dexamethasone immediately before MUA.

Intervention Type: DRUG

Celecoxib

2 weeks per mouth of celecoxib (200 mg daily)

Intervention Type: DRUG

Other Intervention Names

Decadron; Celebrex

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Knee Society

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew P. Abdel, M.D.

Consultant - Knee Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdel Matthew, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

HipKnee Arkansas Foundation

Little Rock, Arkansas, United States

Colorado Joint Replacement

Denver, Colorado, United States

Rush University Medical Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Univ. of Nebraska Medical Center

Omaha, Nebraska, United States

Hospital for Joint Diseases

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

New York - Presbyterian at Columbia University

New York, New York, United States

OrthoCarolina

Charlotte, North Carolina, United States

Duke University Medical Ceter, Dept. of Orthopaedics

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Joint Implant Surgeons

New Albany, Ohio, United States

Rothman Institute

Lansdale, Pennsylvania, United States

Aria 3B Orthopaedic Specialists

Philadelphia, Pennsylvania, United States

Houston Methodist

Houston, Texas, United States

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

15-009075

Identifier Type: -

Identifier Source: org_study_id