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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03615976
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
48
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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

  1. Scoring of patellofemoral disorders( Kujala) score

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

Condition or Disease Intervention/Treatment Phase
  • Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
 N/A

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

  1. Scoring of patellofemoral disorders( Kujala) score

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 progressionIt 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)
Primary Purpose:
Treatment
Official Title:
Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group A

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

Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
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)
Other Names:
  • arthroscopic circumpatellar denervation

    		•
    Active Comparator: GROUP B

    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

    Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
    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)
    Other Names:
  • arthroscopic circumpatellar denervation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of Arthroscopic patellar denervation after open wedge high tibial osteotomy regarding anterior knee pain [all study 2 years average follow up up to 12 months for all cases]

      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

    Other Outcome Measures

    1. Effect of OWHTO on ant. Knee pain and patellar height [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)]

      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

    2. Effect of post-operative rehab protocol in Assiut hospital university [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)]

      Effect of post-operative rehab protocol in Assiut hospital university

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    1. Inclusion criteria:

    2. Age 30-60.

    3. Ant. Knee pain PFOA

    4. Mild to moderate tibiofemoral joint O.A

    5. Without involvement of lateral compartment

    6. Range of motion of at least 120° flexion

    7- BMI less than 30

    1. Exclusion criteria:

    2. Old Age more than 60 and less than 30.

    3. Advanced cases tibiofemoral O.A which need TKR

    4. Flextion deformity more than 15 degree

    5. Varus degree more than 10 degree

    6. Inflammatory disease, such as rheumatoid arthritis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Muhammad Kamel Assiut Asyut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Hatem Galal Zaki, PROFESSOR, ASSIUT HOSPITAL UNIVERSITY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    muhammad kamel muhammad sayed, dr: muhammad kamel muhammad sayed, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03615976
    Other Study ID Numbers:
    • arthroscopy in P.F.O.A
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by muhammad kamel muhammad sayed, dr: muhammad kamel muhammad sayed, Assiut University
    arthroscopy
    Patellofemoral Osteoarthritis
    Additional relevant MeSH terms:
    Patellofemoral Pain Syndrome

    Study Results

    No Results Posted as of Nov 23, 2021