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Clinical Trials/NCT03452423
NCT03452423UnknownNot Applicable

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

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 site in 1 country100 target enrollmentStarted: May 30, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Partial foot pressure as a percentage of body weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ACRFP

Experimental

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: ACRFP (Procedure)

Outcomes

Primary Outcomes

Partial foot pressure as a percentage of body weight

Time Frame: Before intervention, at 3 months and 6 months after intervention

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 Outcomes

  • Partial foot area as a percentage of body mass index (BMI)(Before surgery, at 3 months, and 6 months after intervention)
  • Walking speed(Before surgery, at 3 months, and 6 months after intervention)
  • Step length(Before surgery, at 3 months, and 6 months after intervention)
  • Gait Cadence(Before surgery, at 3 months, and 6 months after intervention)
  • Step width(Before surgery, at 3 months, and 6 months after intervention)
  • The Knee injury and Osteoarthritis Outcome Score (KOOS)(Before surgery, at 3 months, and 6 months after intervention)
  • Single leg stance time(Before surgery, at 3 months, and 6 months after intervention)
  • Axis angle(Before surgery, at 3 months, and 6 months after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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