Phase 4
N=130
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Stiffness Following Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT02739035 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Knee Range of Motion After Manipulation Under Anesthesia — 98.7; 101.2 Degrees — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); Celecoxib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Range of Motion After Manipulation Under Anesthesia |
107.7; 107.6 | 0.81 |
| PRIMARY Knee Range of Motion After Manipulation Under Anesthesia |
107.7; 107.6 | 0.81 |
| SECONDARY Knee Society Functional Score |
64.7; 64.2; 77.3; 74.2 | — |
| SECONDARY Knee Society Knee Score |
65.1; 66.8; 74.2; 68.6 | — |
| SECONDARY Short Form Survey 12-item Version 2 (SF-12v2): Physical Health |
38.7; 37.0; 44.8; 43.3 | — |
| SECONDARY Short Form Survey 12-item Version 2 (SF-12v2): Mental Health |
51.7; 53.7; 54.4; 54.3 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score |
64.2; 58.0; 82.5; 75.7 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score |
68.9; 62.7; 84.1; 79.8 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score |
74.1; 70.3; 81.0; 76.6 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score |
48.5; 52.8; 61.0; 62.2 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life |
49.2; 50.0; 83.0; 67.1 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) |
64.9; 62.7; 72.5; 69.0 | — |
| SECONDARY PROMIS-29 Outcome Form: Physical Function |
41.0; 42.5; 52.2; 45.2 | — |
| SECONDARY PROMIS-29 Outcome Form: Anxiety |
48.3; 48.9; 43.6; 45.5 | — |
| SECONDARY PROMIS-29 Outcome Form: Depression |
46.6; 48.7; 41.0; 46.8 | — |
| SECONDARY PROMIS-29 Outcome Form: Fatigue |
46.6; 48.2; 39.3; 41.5 | — |
| SECONDARY PROMIS-29 Outcome Form: Sleep Disturbance |
54.7; 57.4; 48.3; 48.0 | — |
| SECONDARY PROMIS-29 Outcome Form: Social Activities |
49.2; 51.5; 62.3; 56.1 | — |
| SECONDARY PROMIS-29 Outcome Form: Pain Interference |
56.1; 58.2; 47.4; 56.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
- MUA's scheduled between 6-10 weeks postoperatively
Exclusion Criteria
- Intolerance to NSAIDs
- Renal dysfunction
- Age 90 years
- Primary diagnosis of rheumatoid arthritis
- Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
Data sourced from ClinicalTrials.gov (NCT02739035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.