Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Acquired Fixed Flexion Deformity of the Knee (Disorder)

• Registration Number: NCT02928835
• Lead Sponsor: Universidade Norte do Paraná

Brief Summary

To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were randomly assigned in two groups: control group and Dynasplint group.

Detailed Description

Post-surgical rehabilitation interventions following total knee arthroplasty consist mainly of stretching exercises to improve flexibility and prevent soft tissue fibroses around the joint, thus, avoiding contractures and providing increases in the range of motion at the knee joint. Although knee manipulation and open arthrolysis may improve range of motion after total knee arthroplasty , the results have been variable and additional procedures are frequently necessary. Studies demonstrated the effectiveness of dynamic orthoses in reducing joint contractures after orthopedic surgeries in various joints that require a long rehabilitation period. Therefore, the purpose of the present study was to evaluate the effects of the knee flexion Dynasplint orthosis (KFD) on the length of rehabilitation and range of knee flexion angle after total knee arthroplasty.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-11
• Study Completion: 2013-11
• Status Verified: 2016-10
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients enrolled will have been schedule to receive first prosthesis of the knee:

Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions

Exclusion Criteria

Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The knee flexion angle was assessed in supine position with a universal goniometer	Change from baseline knee flexion angle at 6 months	The outcomes were obtained by one experienced and well-trained physical therapist.

Secondary Outcome Measures

Name	Time	Method
Measures of knee function.	Change from baseline knee flexion angle at 6 months	Assessed by the Knee Society Score (KSS)
Measures for quality of life	Change from baseline knee flexion angle at 6 months	Assessed by Short-form 36 Health Survey (SF-36)

Trial Locations

Locations (1)

Hôpital Jean-Talon; 🇨🇦 Montreal, Quebec, Canada