Anterior Knee Pain SyndromeNCT03615976
Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain
A study testing high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation in people with Anterior Knee Pain Syndrome, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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)
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation
- Keywords
- arthroscopy, Patellofemoral Osteoarthritis
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervationProcedure or surgery
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: all study 2 years average follow up up to 12 months for all cases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Mar 2017
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammad kamel muhammad sayed, Assiut University
- Investigators
- Hatem Galal Zaki, PROFESSOR, Study director, ASSIUT HOSPITAL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615976
- Sponsor's protocol ID
- arthroscopy in P.F.O.A
- Status last verified
- Nov 2021
- First submitted
- 16 Apr 2018
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25563318Ferrari 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.
PubMed 28580253Waryasz 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.
PubMed 18582383Witvrouw 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.
PubMed 15703965Wetzels 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.
PubMed 21596570
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Arthroscopic Patellar Denervation With High Tibial Osteotomy Improve Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT03615976
- Acronym / sponsor ID
- arthroscopy in P.F.O.A
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- arthroscopy, Patellofemoral Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervationgroup 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 B | Active comparator | Procedure: high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervationoperative 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervationAlso: arthroscopic circumpatellar denervationArthroscopy 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) | Procedure or surgery | GROUP B, group A |
Primary outcome
Effect of Arthroscopic patellar denervation after open wedge high tibial osteotomy regarding anterior knee pain
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 25563318Zhao 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.
- Background: PubMed 28580253Ferrari 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.
- Background: PubMed 18582383Waryasz 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.
- Background: PubMed 15703965Witvrouw 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.
- Background: PubMed 21596570Wetzels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem Galal Zaki, PROFESSOR study director
ASSIUT HOSPITAL UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation in people with Anterior Knee Pain Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Arthroscopic patellar denervation after open wedge high tibial osteotomy regarding anterior knee pain (time frame: all study 2 years average follow up up to 12 months for all cases). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615976, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.