Osteoarthritis, KneeSEVERENCT04691466
Study Evaluating the Efficacy of Joint Replacement
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Nicolaus Copernicus University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Joint replacement
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2013to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population with osteoarthritis of the hip or knee.
Who may be able to join
- Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.
Who cannot join
- An inability to understand the Polish language,
- Presence of neuromuscular disease and cognitive impairment,
- Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
- Having rheumatoid arthritis,
- Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15
Bydgoszcz, PL-85-067
Przemysław T Tomasz, MD, PhD, +48575908432, P.Paradowski@cm.umk.pl
Marek K Gojło, MD, PhD, +48503084950, marekgojlo@gmail.com
About this study
Official title: Assessment of Clinical Outcome Following Total Hip and Knee Replacement
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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Joint replacement
- Keywords
- Replacement, Arthroplasty, Patient-relevant outcome measure (PROM), KOOS, HOOS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint replacementProcedure or surgery
Also called Joint arthroplasty
Routinely performed hip- or knee replacement
| Study group | Role | What they receive |
|---|---|---|
| HIP_R | Patients undergoing hip replacement surgery Receives: Procedure: Joint replacement | |
| KNEE_R | Patients undergoing knee replacement surgery Receives: Procedure: Joint replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the patients' opinion about their hip. Change over time
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.
Measured: 12 months
Assessment of the patients' opinion about their knee. Score change over time
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.
Measured: 12 months
Secondary outcomes (4)
Assessment of the quality of life. Score change over time
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.
Measured: 12 months
Pain intensity. Change over time
Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best.
Measured: 12 months
Hip abductors muscle strength. Change over time
Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative.
Measured: 12 months
Range of motion.
Assessment of range of motion in hips and knees, respectively, in following assessments; degrees.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start2 Jan 2013
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Collaborators
- Warmia and Mazury Oncology Centre
- Responsible party
- Principal investigator, Przemyslaw Paradowski, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691466
- Sponsor's protocol ID
- WN758
- Acronym
- SEVERE
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Outcome Following Total Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT04691466
- Acronym / sponsor ID
- SEVERE / WN758
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Replacement, Arthroplasty, Patient-relevant outcome measure (PROM), KOOS, HOOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Collaborators
- Warmia and Mazury Oncology Centre
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIP_R | – | Procedure: Joint replacementPatients undergoing hip replacement surgery |
| KNEE_R | – | Procedure: Joint replacementPatients undergoing knee replacement surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with osteoarthritis of the hip or knee.
Key inclusion criteria (1 listed)
- Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.
Key exclusion criteria (5 listed)
- An inability to understand the Polish language,
- Presence of neuromuscular disease and cognitive impairment,
- Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
- Having rheumatoid arthritis,
- Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint replacementAlso: Joint arthroplastyRoutinely performed hip- or knee replacement | Procedure or surgery | HIP_R, KNEE_R |
Primary outcome
Assessment of the patients' opinion about their hip. Change over time
Time frame: 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
Time frame: 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.
4 secondary outcomes
Assessment of the quality of life. Score change over time
Time frame: 12 months
Pain intensity. Change over time
Time frame: 12 months
Hip abductors muscle strength. Change over time
Time frame: 12 months
Range of motion.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Przemysław T Paradowski, MD, PhD (+48575908432, P.Paradowski@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the patients' opinion about their hip. Change over time (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.