MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Stiffness Following Total Knee Arthroplasty

Treatments: Drug: Celecoxib; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02739035

15-009075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

MUA alone

No Intervention group

Description:

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.

MUA with dexamethasone and celecoxib

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Celecoxib