Functional Recovery After Total Knee Arthroplasty

NCT02156453 | Completed

• 1 other identifier: 126/2556(EC2)
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western Ontario and Mcmaster Universities osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to evaluate functional outcome of the patients is to use the performance-based tests such as the two-minute walk test, but there is still little information regarding its use for evaluating functional recovery in patients receiving total knee arthroplasty. The objectives this study are: 1) to assess the relationship between self-report questionnaires and performance-based tests among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and postoperative functional performance of the patients.

Conditions

Knee Osteoarthritis

Keywords

Functional recovery; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change of the 2-minute walk test (2MWT) from baseline to at 1 year after surgery

  baseline, 6 weeks, 3 months, 6 months and 1 year after surgery

Secondary Outcomes (4)

• Change of the Timed get-up-and-go test (TUG) from baseline to 1 year after surgery

  baseline, 6 weeks, 3 months, 6 months and 1 year after surgery

• Change of the pain scores on the Visual Analog Scale from baseline to 1 year after surgery

  baseline, 6 weeks, 3 months, 6 months and 1 year after surgery

• Change of the functional scores on the WOMAC index (Thai version) from baseline to 1 year after surgery

  baseline, 3 months, 6 months and 1 year after surgery

• Change of the physical function domain of the SF-36 Health Survey from baseline to 1 year after surgery

  baseline, 3 months, 6 months and 1 year after surgery

Study Arms (1)

Total knee arthroplasty

Patients undergoing uncomplicated total knee replacement

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

All patients will undergo total knee replacement using midvastus approach by single surgeon.

Total knee arthroplasty

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive uncomplicated total knee replacement by a single surgeon

You may qualify if:

• Patients who aged between 40-100 years
• Patients who diagnosed with end-stage osteoarthritis of the knee

You may not qualify if:

• Patients who receive total knee replacement on the contralateral side during the past 6 months
• Patients with diseases or conditions that may affect postoperative functional recovery such as severe cardiopulmonary disease
• Unable to participate in postoperative follow-up visits
• Prior surgery on the affected knee, such as high tibial osteotomy
• Patients with complex deformity who require bone grafting or metal augments

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Aasis Unnanuntana, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

TH (1)