OsteoarthritisNCT00668915
Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?
An observational study of Osteoarthritis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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: Patients undergoing primary arthroplasty
Who may be able to join
- Patient above the age of 18 and eligible to provide informed consent.
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee.
- Stepping with the operated leg is allowed after the surgery.
Who cannot join
- Patients unwilling to participate.
- Patients with complications preventing regular rehabilitation, e.g. Myocardial Infarction, Pulmonary Embolism, Pneumonia, and infection or fracture of the joint.
- Patients with any complication that prevents stepping with the operated leg.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Patient above the age of 18 and eligible to provide informed consent.
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee.
- Stepping with the operated leg is allowed after the surgery.
Exclusion criteria:
- Patients unwilling to participate.
- Patients with complications preventing regular rehabilitation, e.g. Myocardial Infarction, Pulmonary Embolism, Pneumonia, and infection or fracture of the joint.
- Patients with any complication that prevents stepping with the operated leg.
Design:
- 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.
- During the postoperative hospitalization period, hemoglobin and CRP levels will be checked, and the patients will be evaluated for complications.
- 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.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Primary arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford hip and knee score
Grip strength
Timed up and go test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668915
- Sponsor's protocol ID
- rehabtjr-HMO-CTIL
- Status last verified
- Apr 2008
- First submitted
- 28 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?
- ClinicalTrials.gov ID
- NCT00668915
- Acronym / sponsor ID
- rehabtjr-HMO-CTIL
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 29 Apr 2008 (estimated)
- 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.
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.
Detailed description
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:
- Patient above the age of 18 and eligible to provide informed consent.
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee.
- Stepping with the operated leg is allowed after the surgery.
Exclusion criteria:
- Patients unwilling to participate.
- Patients with complications preventing regular rehabilitation, e.g. Myocardial Infarction, Pulmonary Embolism, Pneumonia, and infection or fracture of the joint.
- Patients with any complication that prevents stepping with the operated leg.
Design:
- 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.
- During the postoperative hospitalization period, hemoglobin and CRP levels will be checked, and the patients will be evaluated for complications.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Primary arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary arthroplasty
Key inclusion criteria (3 listed)
- Patient above the age of 18 and eligible to provide informed consent.
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee.
- Stepping with the operated leg is allowed after the surgery.
Key exclusion criteria (3 listed)
- Patients unwilling to participate.
- Patients with complications preventing regular rehabilitation, e.g. Myocardial Infarction, Pulmonary Embolism, Pneumonia, and infection or fracture of the joint.
- Patients with any complication that prevents stepping with the operated leg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxford hip and knee score
Grip strength
Timed up and go test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2008.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 3 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 29 Apr 2008. 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 Israel. 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 Leonid Kandel, MD (972-50-787-4328, kandel@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford hip and knee score. The study lists 3 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 29 Apr 2008.