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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of Knees
• Intervention / Treatment: Procedure: ACRFP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Buddhist Taipei Tzu Chi General Hospital
    • Contact: Shuo-Suei Hung, PhD; Phone Number: +886266289009; Email: hung_ortho@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACRFP; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Gait Cadence	The number of steps per minute	Before surgery, at 3 months, and 6 months after intervention
Walking speed	The velocity of each single step	Before surgery, at 3 months, and 6 months after intervention
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
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
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
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

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Principal Investigator: Shuo-Suei Hung, PhD, Buddhist Taipei Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2017
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Gait; Osteoarthritis of knees; Arthroscopic cartilage regeneration facilitating procedure (ACRFP); Foot pressure
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 05-XD41-074

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No