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The Effectiveness of Arthroscopic Cartilage Regeneration Facilitating Procedure for Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis of Knees

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ACRFP
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Knees focused on measuring Osteoarthritis of knees, Arthroscopic cartilage regeneration facilitating procedure (ACRFP), Foot pressure, Gait

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the ages 20 and 85 who will receive ACRFP for treatment of osteoarthritis in the knee joints

Exclusion Criteria:

  • Patients with walking disability

Sites / Locations

  • Buddhist Taipei Tzu Chi General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACRFP

Arm Description

Patient suffering from osteoarthritis of knee joints, and planning to receive ACRFP, are enrolled into this study. Gait pattern is obtained preoperatively, 3 months, and 6 months postoperatively.

Outcomes

Primary Outcome Measures

Partial foot pressure as a percentage of body weight
ach footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the percentage of body weight.

Secondary Outcome Measures

The Knee injury and Osteoarthritis Outcome Score (KOOS)
A questionnaire to assess the patient's subjective symptoms about their knee joints and associated problems caused by the disorders
Partial foot area as a percentage of body mass index (BMI)
Each footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the body mass index (BMI).
Gait Cadence
The number of steps per minute
Walking speed
The velocity of each single step
Single leg stance time
The length of time of each foot at the stance phase
Step length
The distance between the first point of contact of the foot with the ground and that of the contralateral foot
Step width
The distance between the center of the heel contact and the following one, calculated perpendicularly to the direction of the horizontal axis drawn between the feet
Axis angle
the angle formed by the medial tangent of the foot and the line from the second/third toe to the center of the heel

Full Information

First Posted
February 1, 2018
Last Updated
February 26, 2018
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03452423
Brief Title
The Effectiveness of Arthroscopic Cartilage Regeneration Facilitating Procedure for Patients With Knee Osteoarthritis
Official Title
The Effect on Gait Pattern in Patients Receiving Arthroscopic Cartilage Regeneration Facilitating Procedure (ACRFP) for Treatment of Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to discuss the effect of gait pattern in patients receiving arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of osteoarthritis of knees.
Detailed Description
Pain during gait is the most common and problematic symptom in individuals with osteoarthritis (OA) of knee joints. Limited range of motion, reduced walking speed, and a shortened stride length are also occasionally observed. These changes may be secondary or compensatory phenomena adopted by individuals to lessen the load on the OA-affected knees. It is generally agreed that medial plica can produce symptoms in the knee joint, and can be successfully treated by arthroscopic resection when it becomes inflamed, thickened, and fibrotic. In 2006, Lyu and Hsu reported that medial plica had strong correlation with medial compartment osteoarthritis of knees. In their further studies disclosing the kinematic relationship of the medial plica with the medial femoral condyle found that medial plica might cause some degree of abrasion on the surface of medial femoral condyle during knee motion. The repeated injuries elicited by this abrasion phenomenon might trigger some inflammatory process to gradually damage the cartilage of knee. Based on these findings, Lyu developed a concept of arthroscopic cartilage regeneration facilitating procedure (ACRFP) by arthroscopic resection of the medial plica, in addition to both medial and lateral capsular release, for the treatment of osteoarthritis of the knee joint. The clinical outcome of this procedure by eradication of the abrasion phenomenon caused by the tight, fibrotic, and hypertrophied medial plica, with decompression of the patellofemoral joint, the pain in most patients could be reduced, and the degenerative process in the medial compartment of some patients might be decelerated or arrested. During the ACRFP, additional procedures such as synovectomy, abrasiochondroplasty, or partial menisectomy may also be carried out when necessary. It has been found that the elimination of the existing detrimental factors may provide a preferable environment for regeneration of the damaged cartilage. Although the results of ACRFP for treatment of osteoarthritis of knee has been supported by several researches as being an effective method, it still lacks investigations on the gait pattern after such procedure. Therefore, the aim of this study is to discuss the effectiveness of the ACRFP for the patients with osteoarthritis of knee joints, specifically focused on their gait pattern.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knees
Keywords
Osteoarthritis of knees, Arthroscopic cartilage regeneration facilitating procedure (ACRFP), Foot pressure, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACRFP
Arm Type
Experimental
Arm Description
Patient suffering from osteoarthritis of knee joints, and planning to receive ACRFP, are enrolled into this study. Gait pattern is obtained preoperatively, 3 months, and 6 months postoperatively.
Intervention Type
Procedure
Intervention Name(s)
ACRFP
Intervention Description
Arthroscopic cartilage regeneration facilitating procedure (ACRFP) is a set of surgical procedures that combines resection of medial plica, medial and lateral capsular release, synovectomy of focal synovitis, and chondroplasty of loosened cartilage flaps as a rationale for the deliberate arthroscopic management of osteoarthritic knee.
Primary Outcome Measure Information:
Title
Partial foot pressure as a percentage of body weight
Description
ach footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the percentage of body weight.
Time Frame
Before intervention, at 3 months and 6 months after intervention
Secondary Outcome Measure Information:
Title
The Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
A questionnaire to assess the patient's subjective symptoms about their knee joints and associated problems caused by the disorders
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Partial foot area as a percentage of body mass index (BMI)
Description
Each footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the body mass index (BMI).
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Gait Cadence
Description
The number of steps per minute
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Walking speed
Description
The velocity of each single step
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Single leg stance time
Description
The length of time of each foot at the stance phase
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Step length
Description
The distance between the first point of contact of the foot with the ground and that of the contralateral foot
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Step width
Description
The distance between the center of the heel contact and the following one, calculated perpendicularly to the direction of the horizontal axis drawn between the feet
Time Frame
Before surgery, at 3 months, and 6 months after intervention
Title
Axis angle
Description
the angle formed by the medial tangent of the foot and the line from the second/third toe to the center of the heel
Time Frame
Before surgery, at 3 months, and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages 20 and 85 who will receive ACRFP for treatment of osteoarthritis in the knee joints Exclusion Criteria: Patients with walking disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuan-Hsin Yen, BS
Phone
+886933301155
Email
Yanlisa0728@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo-Suei Hung, PhD
Phone
+886970333582
Email
hung_ortho@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo-Suei Hung, PhD
Organizational Affiliation
Buddhist Taipei Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Taipei Tzu Chi General Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo-Suei Hung, PhD
Phone
+886266289009
Email
hung_ortho@yahoo.com.tw

12. IPD Sharing Statement

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The Effectiveness of Arthroscopic Cartilage Regeneration Facilitating Procedure for Patients With Knee Osteoarthritis

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