Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00668915
First received: April 28, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Oxford hip and knee score [ Designated as safety issue: No ]
  • Grip strength [ Designated as safety issue: No ]
  • Timed up and go test [ Designated as safety issue: No ]

Estimated Enrollment: 200
Groups/Cohorts
A
Primary arthroplasty

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing primary arthroplasty

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668915

Contacts
Contact: Leonid Kandel, MD 972-50-787-4328 kandel@hadassah.org.il

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00668915     History of Changes
Other Study ID Numbers: rehabtjr-HMO-CTIL
Study First Received: April 28, 2008
Last Updated: April 28, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014