NCT00668915

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

April 29, 2008

Status Verified

April 1, 2008

First QC Date

April 28, 2008

Last Update Submit

April 28, 2008

Conditions

Outcome Measures

Primary Outcomes (3)

  • Oxford hip and knee score

  • Grip strength

  • Timed up and go test

Study Arms (1)

A

Primary arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing primary arthroplasty

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 29, 2008

Last Updated

April 29, 2008

Record last verified: 2008-04

Locations