NCT03615976

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. 1.Scoring of patellofemoral disorders( Kujala) score
  2. 2.Knee Injury and Osteoarthritis Outcome Score (KOOS)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

3.8 years

First QC Date

April 16, 2018

Last Update Submit

November 19, 2021

Conditions

Keywords

arthroscopyPatellofemoral Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    all study 2 years average follow up up to 12 months for all cases

Other Outcomes (2)

  • 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 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)

Study Arms (2)

group A

ACTIVE COMPARATOR

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

GROUP B

ACTIVE COMPARATOR

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

Interventions

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)

Also known as: arthroscopic circumpatellar denervation
GROUP Bgroup A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • BMI less than 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Kamel

Asyut, Asyut Governorate, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 25563318BACKGROUND
  • 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.

    PMID: 28580253BACKGROUND
  • 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.

    PMID: 18582383BACKGROUND
  • 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.

    PMID: 15703965BACKGROUND
  • 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.

    PMID: 21596570BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Hatem Galal Zaki, PROFESSOR

    ASSIUT HOSPITAL UNIVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr: muhammad kamel muhammad sayed

Study Record Dates

First Submitted

April 16, 2018

First Posted

August 6, 2018

Study Start

March 1, 2017

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations