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Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain

Primary Purpose

Anterior Knee Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Knee Pain Syndrome focused on measuring arthroscopy, Patellofemoral Osteoarthritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers
  1. Inclusion criteria:

    1. Age 30-60.
    2. Ant. Knee pain PFOA
    3. Mild to moderate tibiofemoral joint O.A
    4. Without involvement of lateral compartment
    5. Range of motion of at least 120° flexion

    7- BMI less than 30

  2. Exclusion criteria:

    1. Old Age more than 60 and less than 30.
    2. Advanced cases tibiofemoral O.A which need TKR
    3. Flextion deformity more than 15 degree
    4. Varus degree more than 10 degree
    5. Inflammatory disease, such as rheumatoid arthritis

Sites / Locations

  • Muhammad Kamel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

GROUP B

Arm Description

group A with patellofemoral pain resistant to medical and physiotherapy assessment by pre operative knee score HIGH TIBIAL osteotomy will be done for all patients with arthroscopic patellar denervation will be done

operative group B with patellofemoral pain resistant to medical and physiotherapy assessment by pre operative knee score HIGH TIBIAL osteotomy will be done without arthroscopic patellar denervation

Outcomes

Primary Outcome Measures

Effect of Arthroscopic patellar denervation after open wedge high tibial osteotomy regarding anterior knee pain
The aim is to evaluate the effect of arthroscopic denervation of patella In management of anterior Knee pain after High tibial osteotomy operation The effect of denervation was statistically and clinically evaluated using the Knee injury and Osteoarthritis Outcome Score (KOOS) and Kujala (anterior knee pain score) score

Secondary Outcome Measures

Full Information

First Posted
April 16, 2018
Last Updated
November 19, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03615976
Brief Title
Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain
Official Title
Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

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

5. Study Description

Brief Summary
Arthroscopy will be done in all cases before osteotomy to assess lat. Comp and grade of patellofemoral O.A Arthroscopic patellar denervation with vaper or diathermy will be done plus open wedge high tibial osteotomy in one group and other group OWHTO only will be done comparing the rustles of two groups to assess the efficacy of this procedure followed by an average follow up to 12 months. And follow up( 6th weeks ,3rd month ,6th month , 12th month) By clinical examinationan and x-ray and knee scores Scoring of patellofemoral disorders( Kujala) score Knee Injury and Osteoarthritis Outcome Score (KOOS)
Detailed Description
Patellofemoral joint osteoarthritis (P.F.O.A) is a highly prevalent disease and an important source of anterior knee pain and Disability during daily activities (kneeling, squatting, climbing stairs, getting up from low chair.( 3,5) Coexisting Patellofemoral osteoarthritis (PFOA) and Tibiofemoral O.A disease is a common radiographic pattern of knee OA observed in older adults with knee pain. In addition, symptomatic disease and reduced function are more likely to be found if radiographic OA changes are present in both the TF and PF compartment also it demonstrates features distinctly different from those observed in Tibiofemoral O.A without presence of Patellofemoral osteoarthritis (PFOA) . More specifically, "Moderate/Severe PFOA" seems to be associated with lower limb impairments of lower knee extension strength and limitations of knee range of motion. (14) (14,6) High tibial osteotomy (HTO) with medial opening wedge has gained in popularity over recent years and is used for the treatment of medial compartmental osteoarthritis (OA) but not for anterior knee pain (P.F.O.A). This procedure is appealing because of the high preservation of the knee joint relative to total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (9) High tibial osteotomy (HTO) can cause alterations in patellar height (Patella baja) and alignment which can increase contact stress and eventually lead to anterior Knee pain (13,17) The findings indicate that anterior knee pain might be due to OA progression in the patellofemoral joint after HTO (11,12) Patellofemoral OA and Cartilage injuries in PF joints tended to progress after Open Wedge HTO which proven by second lock arthroscopy. a significant proportion of patients (about 20%) had grade II OA of the patellofemoral joint at final follow-Up 2yrs. (7,8) Anterior knee pain also were quite high (28% and 32% in the opening- and closing-wedge groups) after surgery. Although there are several possible causes for anterior knee pain after HTO, such as surgery itself, alteration of patellar alignment, and OA change in the patellofemoral joint ,patients with severe anterior knee pain were found to have grade II patellofemoral OA. (7,8) In spite of its high prevalence, treatment of this painful disorder (PFOA) is challenging due to the diversity of causes of the disorder and the lack of knowledge on articular regeneration, little information is available in the literature about the best conservative or surgical treatment options.(3,5) Non-operative treatment options for patellofemoral osteoarthritis include patellar bracing, physical therapy intervention, corticosteroid injections, patellar taping, and strengthening of the quadriceps muscle, this is considered a potential short-term fix for many patients. Ultimately, surgical treatment is necessary to provide a long-term solutions. which include Patellofemoral arthroplasty, total knee replacement with patellar resurfacing,(5) Arthroscopic circumpatellar denervation, this joint-preserving, minimal invasive technique provides relief of anterior knee pain. Moreover, this technique provide a faster recovery period immediately after surgery and less morbidity (1,18,19) Arthroscopy will be done in all cases before osteotomy to assess lat. Comp and grade of patellofemoral O.A Arthroscopic patellar denervation with vaper or diathermy will be done plus open wedge high tibial osteotomy in one group and other group OWHTO only will be done comparing the rustles of two groups to assess the efficacy of this procedure followed by an average follow up to 12 months. And follow up( 6th weeks ,3rd month ,6th month , 12th month) By clinical examinationan and x-ray and knee scores Scoring of patellofemoral disorders( Kujala) score Knee Injury and Osteoarthritis Outcome Score (KOOS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Knee Pain Syndrome
Keywords
arthroscopy, Patellofemoral Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is prospective case series study The aim is to evaluate the effect of arthroscopic denervation of patella In management of ant. Knee after High tibial osteotomy operation in pain reduction, improving knee joint function, quality of life, and deferring arthritic progression
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
group A with patellofemoral pain resistant to medical and physiotherapy assessment by pre operative knee score HIGH TIBIAL osteotomy will be done for all patients with arthroscopic patellar denervation will be done
Arm Title
GROUP B
Arm Type
Active Comparator
Arm Description
operative group B with patellofemoral pain resistant to medical and physiotherapy assessment by pre operative knee score HIGH TIBIAL osteotomy will be done without arthroscopic patellar denervation
Intervention Type
Procedure
Intervention Name(s)
high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
Other Intervention Name(s)
arthroscopic circumpatellar denervation
Intervention Description
Arthroscopy will be done in all cases before osteotomy to assess lat. Comp and grade of patellofemoral O.A Arthroscopic patellar denervation with vaper or diathermy will be done plus open wedge high tibial osteotomy in one group and other group OWHTO only will be done comparing the rustles of two groups to assess the efficacy of this procedure followed by an average follow up to 12 months. And follow up( 6th weeks ,3rd month ,6th month , 12th month) By clinical examinationan and x-ray and knee scores Scoring of patellofemoral disorders( Kujala) score Knee Injury and Osteoarthritis Outcome Score (KOOS)
Primary Outcome Measure Information:
Title
Effect of Arthroscopic patellar denervation after open wedge high tibial osteotomy regarding anterior knee pain
Description
The aim is to evaluate the effect of arthroscopic denervation of patella In management of anterior Knee pain after High tibial osteotomy operation The effect of denervation was statistically and clinically evaluated using the Knee injury and Osteoarthritis Outcome Score (KOOS) and Kujala (anterior knee pain score) score
Time Frame
all study 2 years average follow up up to 12 months for all cases
Other Pre-specified Outcome Measures:
Title
Effect of OWHTO on ant. Knee pain and patellar height
Description
Effect of OWHTO on patellar height patellar height (alta or baja) may be evaluated by various methods in the lateral x-ray. We used the Insall-Salvati ratio with a normal ratio of 0.8-1.2. This compared the length of the patellar tendon with the patellar height
Time Frame
We will compare the score before and after the surgery and check if it is statically significant. Followed by an average follow up to 12 months ( 6th weeks ,3rd month ,6th month , 12th month)
Title
Effect of post-operative rehab protocol in Assiut hospital university
Description
Effect of post-operative rehab protocol in Assiut hospital university
Time Frame
We will compare the score before and after the surgery and check if it is statically significant.followed by an average follow up to 12 months ( 6th weeks ,3rd month ,6th month , 12th month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age 30-60. Ant. Knee pain PFOA Mild to moderate tibiofemoral joint O.A Without involvement of lateral compartment Range of motion of at least 120° flexion 7- BMI less than 30 Exclusion criteria: Old Age more than 60 and less than 30. Advanced cases tibiofemoral O.A which need TKR Flextion deformity more than 15 degree Varus degree more than 10 degree Inflammatory disease, such as rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Galal Zaki, PROFESSOR
Organizational Affiliation
ASSIUT HOSPITAL UNIVERSITY
Official's Role
Study Director
Facility Information:
Facility Name
Muhammad Kamel
City
Assiut
State/Province
Asyut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25563318
Citation
Zhao G, Liu Y, Yuan B, Shen X, Qu F, Wang J, Qi W, Zhu J, Liu Y. Arthroscopic patelloplasty and circumpatellar denervation for the treatment of patellofemoral osteoarthritis. Chin Med J (Engl). 2015 Jan 5;128(1):79-84. doi: 10.4103/0366-6999.147820.
Results Reference
background
PubMed Identifier
28580253
Citation
Ferrari MB, Sanchez G, Chahla J, Moatshe G, LaPrade RF. Arthroscopic Patellar Lateral Facetectomy. Arthrosc Tech. 2017 Mar 20;6(2):e357-e362. doi: 10.1016/j.eats.2016.10.002. eCollection 2017 Apr.
Results Reference
background
PubMed Identifier
18582383
Citation
Waryasz GR, McDermott AY. Patellofemoral pain syndrome (PFPS): a systematic review of anatomy and potential risk factors. Dyn Med. 2008 Jun 26;7:9. doi: 10.1186/1476-5918-7-9.
Results Reference
background
PubMed Identifier
15703965
Citation
Witvrouw E, Werner S, Mikkelsen C, Van Tiggelen D, Vanden Berghe L, Cerulli G. Clinical classification of patellofemoral pain syndrome: guidelines for non-operative treatment. Knee Surg Sports Traumatol Arthrosc. 2005 Mar;13(2):122-30. doi: 10.1007/s00167-004-0577-6. Epub 2005 Feb 10.
Results Reference
background
PubMed Identifier
21596570
Citation
Wetzels T, Bellemans J. Patellofemoral osteoarthritis treated by partial lateral facetectomy: results at long-term follow up. Knee. 2012 Aug;19(4):411-5. doi: 10.1016/j.knee.2011.04.005. Epub 2011 May 18.
Results Reference
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Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain

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