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

Osteoarthritis of Knees Clinical Trial

Official title:

The Effect on Gait Pattern in Patients Receiving Arthroscopic Cartilage Regeneration Facilitating Procedure (ACRFP) for Treatment of Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452423
• Other study ID #: 05-XD41-074
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2018
• Last updated: February 26, 2018
• Start date: May 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Chuan-Hsin Yen, BS
• Phone: +886933301155
• Email: Yanlisa0728[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knees
• Osteoarthritis, Knee

Intervention

Procedure:
• ACRFP
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.

Locations

Country	Name	City	State
Taiwan	Buddhist Taipei Tzu Chi General Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before intervention, at 3 months and 6 months after intervention
Secondary	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	Before surgery, at 3 months, and 6 months after intervention
Secondary	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).	Before surgery, at 3 months, and 6 months after intervention
Secondary	Gait Cadence	The number of steps per minute	Before surgery, at 3 months, and 6 months after intervention
Secondary	Walking speed	The velocity of each single step	Before surgery, at 3 months, and 6 months after intervention
Secondary	Single leg stance time	The length of time of each foot at the stance phase	Before surgery, at 3 months, and 6 months after intervention
Secondary	Step length	The distance between the first point of contact of the foot with the ground and that of the contralateral foot	Before surgery, at 3 months, and 6 months after intervention
Secondary	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	Before surgery, at 3 months, and 6 months after intervention
Secondary	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	Before surgery, at 3 months, and 6 months after intervention