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Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy

Primary Purpose

Osteo Arthritis Knee

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age younger than 65 years
  2. Medial joint line tenderness
  3. BMI less than 30
  4. Varus tibiofemoral malalignment
  5. Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
  6. Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2
  7. No associated ligamentous functional instability

Exclusion Criteria:

  1. Age older than 65 years
  2. Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
  3. Flexion contracture of greater than 15 degrees
  4. Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection

Sites / Locations

  • Assiut University HospitalsRecruiting
  • AssiutU HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

osteoarthritic with genu varus

Arm Description

initial arthroscopy and high tibial osteotomy to be followed later by a second look arthroscopy with plate removal

Outcomes

Primary Outcome Measures

Arthroscopic assessment of cartilage regeneration after high tibial osteotomy
By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage. Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone. Grade III is fissuring of the cartilage with a diameter > 0.5 inches with an area reaching subchondral bone. The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.

Secondary Outcome Measures

Post-operative limb alignment
by use of bilateral standing anteroposterior full-length views of both lower limbs before high tibial osteotomy and at time of plate removal. The tibiofemoral angle will be measured to detect the degree of varus correction.

Full Information

First Posted
August 28, 2020
Last Updated
July 21, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04541342
Brief Title
Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy
Official Title
Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.
Detailed Description
Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi experimental one group pretest posttest study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteoarthritic with genu varus
Arm Type
Experimental
Arm Description
initial arthroscopy and high tibial osteotomy to be followed later by a second look arthroscopy with plate removal
Intervention Type
Procedure
Intervention Name(s)
initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal
Intervention Description
It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space.Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy.All patients will undergo initial arthroscopy before high tibial osteotomy (HTO). During arthroscopy, debridement of the degenerate tissues and meniscal tears if present will be performed. Then opening-wedge high tibial osteotomy (OWHTO) will be performed and fixed by a plate system. Second-look arthroscopy will be conducted at the time of plate removal after healing of the osteotomy. This will be after about 6 months up to one year.
Primary Outcome Measure Information:
Title
Arthroscopic assessment of cartilage regeneration after high tibial osteotomy
Description
By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage. Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone. Grade III is fissuring of the cartilage with a diameter > 0.5 inches with an area reaching subchondral bone. The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.
Time Frame
6 months after high tibial osteotomy
Secondary Outcome Measure Information:
Title
Post-operative limb alignment
Description
by use of bilateral standing anteroposterior full-length views of both lower limbs before high tibial osteotomy and at time of plate removal. The tibiofemoral angle will be measured to detect the degree of varus correction.
Time Frame
6 months after high tibial osteotomy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age younger than 65 years Medial joint line tenderness BMI less than 30 Varus tibiofemoral malalignment Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2 No associated ligamentous functional instability Exclusion Criteria: Age older than 65 years Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4) Flexion contracture of greater than 15 degrees Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mohamed, Bachelor
Phone
+201064986480
Email
am.sayed.94@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Farouk, MD
Phone
+201005460273
Email
aymanfaaa@aun.edu.eg
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Name
AssiutU Hospitals
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
28291955
Citation
Kim KI, Seo MC, Song SJ, Bae DK, Kim DH, Lee SH. Change of Chondral Lesions and Predictive Factors After Medial Open-Wedge High Tibial Osteotomy With a Locked Plate System. Am J Sports Med. 2017 Jun;45(7):1615-1621. doi: 10.1177/0363546517694864. Epub 2017 Mar 14.
Results Reference
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PubMed Identifier
29533246
Citation
Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018 Oct;476(10):2101-2104. doi: 10.1007/s11999.0000000000000255. No abstract available.
Results Reference
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PubMed Identifier
12893144
Citation
Koshino T, Wada S, Ara Y, Saito T. Regeneration of degenerated articular cartilage after high tibial valgus osteotomy for medial compartmental osteoarthritis of the knee. Knee. 2003 Sep;10(3):229-36. doi: 10.1016/s0968-0160(03)00005-x.
Results Reference
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Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy

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