Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Replacement, Arthroplasty, Patient-relevant outcome measure (PROM), KOOS, HOOS
Brief summary
Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.
Interventions
PROCEDUREJoint replacement
Routinely performed hip- or knee replacement
Sponsors
Warmia and Mazury Oncology Centre
Nicolaus Copernicus University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.
Exclusion criteria
1. An inability to understand the Polish language, 2. Presence of neuromuscular disease and cognitive impairment, 3. Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery, 4. Having rheumatoid arthritis, 5. Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the patients' opinion about their hip. Change over time | 12 months | Change between the following assessments as measured with the Hip disability and Osteoarthritis Outcome Score (HOOS) in patients undergoing total hip replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points. |
| Assessment of the patients' opinion about their knee. Score change over time | 12 months | Change between the following assessments as measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing total knee replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity. Change over time | 12 months | Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best. |
| Range of motion. | 12 months | Assessment of range of motion in hips and knees, respectively, in following assessments; degrees. |
| Hip abductors muscle strength. Change over time | 12 months | Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative. |
| Assessment of the quality of life. Score change over time | 12 months | Results of the generic PROM, the Short Form Health Survey-36 (SF-36) in both, patients undergoing hip and knee replacement; 0-100 points, worst to best. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | 12 months | Measurement of weight in kilograms and height in meters to combined to report BMI in kg/m\^2; to be measured twice, before intervention and after 12 months. |
| Activity | 12 months | Measured with the Tegner Activity Score (TAS); 1-10 points, worst to best; to be measured twice, before intervention and after 12 months. |
Countries
Poland
Contacts
Primary ContactPrzemysław T Paradowski, MD, PhD
Backup ContactMarek K Gojło, MD, PhD
Outcome results
None listed