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

April 28, 2008
April 28, 2008
 
 
  • 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 ]
Same as current
No Changes Posted
 
 
 
 
 
Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?
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
Observational Model: Cohort
Time Perspective: Prospective
 
Probability Sample

Patients undergoing primary arthroplasty

Osteoarthritis
 
A
Primary arthroplasty
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
 
 

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.
Both
18 Years and older
No
Contact: Leonid Kandel, MD 972-50-787-4328 kandel@hadassah.org.il
Israel
 
NCT00668915
rehabtjr-HMO-CTIL
No
 
Hadassah Medical Organization
 
 
Hadassah Medical Organization
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP