Osteoarthritis Clinical Trial
Official title:
Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?
Total joint arthroplasty are common operations among the elderly population. The
postoperative patients' rehabilitation process may be influenced by a variety of factors,
such as age, BMI, perioperative hemoglobin levels, pain perception, comorbidities, etc.
Nevertheless, only a few well controlled studies evaluated the effect of various factors on
patients' rehabilitation short-term outcome. Furthermore, no scale has been developed, that
can predict patients' rehabilitation and functioning levels 6 weeks postoperatively. In the
current study we wish to evaluate the effect on patients' function that the following
factors have: age, BMI, admission and discharge hemoglobin levels, pain perception, type of
operation (TKA versus THA), intensity of postoperative physiotherapy, involvement of other
joints by the primary pathology, comorbidities, and self assessed health status.
In order to quantify patients' level of functioning, several tests will be used: hand grip
strength, Timed up and go test (TUG) and Oxford knee and hip score. The factors that will be
found statistically significantly associated with level of functioning, will be used in an
attempt to develop a scale that will predict the level of functioning 6 weeks
postoperatively.
Such a scale can allow preoperative identification of patients at high risk of postoperative
low functioning levels and the application of a unique rehabilitation program, for only
these patients, in order to optimize their functioning.
This is a prospective, analytical, approximately 6 months long study.
Population:
Approximately a 100 patients, scheduled for an elective arthroplasty will be recruited for
the study:
- Males and females above 18 years of age, speaking Hebrew, English or Russian, scheduled
for an elective unilateral (one joint) primary total joint arthroplasty of hip or knee.
- Available for follow up 1.5-2 months after the surgery.
- Willing to participate in the study.
Inclusion criteria:
1. Patient above the age of 18 and eligible to provide informed consent.
2. Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip
or knee.
3. Stepping with the operated leg is allowed after the surgery.
Exclusion criteria:
1. Patients unwilling to participate.
2. Patients with complications preventing regular rehabilitation, e.g. Myocardial
Infarction, Pulmonary Embolism, Pneumonia, and infection or fracture of the joint.
3. Patients with any complication that prevents stepping with the operated leg.
Design:
1. Prior to the scheduled operation, the following data regarding the patient will be
collected:
- Gender, age, height, weight.
- Comorbidities (using Katz Score).
- Type of scheduled operation.
- Involvement by the primary pathology of joints other than the one being operated
(by patient questioning).
- Hemoglobin level at admission.
- Self assessed health status (by patient questioning).
- Pain perception in the operated leg (using VAS Score).
In addition, the following tests will be performed:
- Evaluation of muscle strength using handgrip machine.
- Evaluation of motor functioning level using the TUG test and the Oxford knee and
hip score.
2. During the postoperative hospitalization period, hemoglobin and CRP levels will be
checked, and the patients will be evaluated for complications.
3. In the follow up visit, the following data will be collected:
- Complications after discharge from hospital.
- Blood transfusions in this period.
- Duration of time in rehabilitation program, and intensity of physiotherapy given.
During the visit, the following tests will be performed:
- Evaluation of muscle strength using handgrip machine.
- Evaluation of motor functioning level, similar to the one performed preoperatively,
using the TUG test and the Oxford knee and hip score.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A | |
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |