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

NCT ID: NCT03615976

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Knee Pain Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

arthroscopy Patellofemoral Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation

Intervention Type PROCEDURE

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)

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

Group Type ACTIVE_COMPARATOR

high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

arthroscopic circumpatellar denervation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

muhammad kamel muhammad sayed

dr: muhammad kamel muhammad sayed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hatem Galal Zaki, PROFESSOR

Role: STUDY_DIRECTOR

ASSIUT HOSPITAL UNIVERSITY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muhammad Kamel

Asyut, Asyut Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25563318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28580253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18582383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15703965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21596570 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

arthroscopy in P.F.O.A

Identifier Type: -

Identifier Source: org_study_id