Clinical trial NCT03452423: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of Knees
Keywords: Osteoarthritis of knees
Arthroscopic cartilage regeneration facilitating procedure (ACRFP)
Foot pressure
Gait
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Partial foot pressure as a percentage of body weight
timeFrame: Before intervention, at 3 months and 6 months after intervention
Secondary outcomes:
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Partial foot area as a percentage of body mass index (BMI)
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Gait Cadence
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Walking speed
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Single leg stance time
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Step length
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Step width
timeFrame: Before surgery, at 3 months, and 6 months after intervention
measure: Axis angle
timeFrame: Before surgery, at 3 months, and 6 months after intervention
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Buddhist Taipei Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Taipei Tzu Chi General Hospital
name: Shuo-Suei Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: