Management of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis
Evaluation of the Results of High Tibial Osteotomy with or Without Lateral Patellar Facetectomy in Treatment of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis; a Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will undergo OWHTO in a standardized fashion by the same team of surgeons.
They will be randomly divided into 2 groups either OWHTO with arthroscopic partial lateral patellar facetectomy or OWHTO without arthroscopic partial lateral patellar facetectomy in a 1:1 ratio.
The patient will be placed supine on the operating table. After the induction of spinal anesthesia, a knee examination will be performed to evaluate for any concurrent pathology and to assess for knee range of motion, patellar mobility, position, instability, and patellar crepitus during knee flexion. A well-padded thigh tourniquet will be placed on the upper thigh of the operative leg to maintain a bloodless field. The surgical leg will be prepared and draped in a sterile fashion, the leg exsanguinated, and the tourniquet inflated. an arthroscope will be inserted through the anteromedial, anterolateral and suprapatellar portals to access the entire perimeter of the patella. The joint will be insufflated with normal saline and visualized with a 30 degree arthroscope. Diagnostic arthroscopy will be performed in all cases to assess PF articular cartilage degeneration, classify the cartilage defect using the Outterbridge classification , assess the lateral compartment and exclude any other pathology. An arthroscopic shaver will be inserted into the knee and any notable adhesions will be removed. Any meniscal, cartilage, or ligamentous injury may be treated first. The knee will be taken throughout a range of motion to directly visualize the impingement of the lateral patellar facet against the trochlea. Next, a radiofrequency probe will be used to outline the area to be resected along the lateral patellar facet While maintaining the knee at 20 degree of flexion, a 5.5-mm burr is introduced, and under arthroscopic visualization, the lateral patellar osteophyte and the overhanging portion of the lateral facet will be carefully resected. Once the bony resection is complete, the knee is dynamically re-evaluated (through flexion and extension) for residual impingement and to assess for improvements in patellar mobility. Patellar tracking will be assessed to verify that there is no catching in flexion and that patellar mobility is improved.
After arthroscopic partial lateral patellar facetectomy, all patients will undergo OWHTO. All procedures will be performed based on the technique recommended by the AO international knee expert group. Biplanar osteotomy, which comprises osteotomies in the axial and frontal planes, was performed in all cases. Ascending frontal osteotomy, leaving the tibial tuberosity on the distal fragment, was also performed. All osteotomies will be performed without the use of additional bone grafts, and the opening of the osteotomy will be maintained with a Tomofix plate (Orthomed-E Co., Egypt). Wound closure was performed in layers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Tarek Ahmed, Assistant lecturer
- Phone Number: 01033667677
- Email: Ahmed.Tarek@med.sohag.edu.eg
Study Locations
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Sohag, Egypt
- Recruiting
- Faculty of medicine, Sohag university
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Contact:
- Moustafa Ismail, Assistant Professor
- Phone Number: 01003142740
- Email: mostafa.ismael79@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 35-60years
- Mild to moderate TFOA (G I-II-III) Kellgren-Lawrence (KL) scale (16)
- Anterior knee pain (PFOA)
- No involvement of the lateral compartment
- range of motion of at least 120° flexion
- Body mass index (BMI) <30kg/m2
- varus angle degree <10°
Exclusion Criteria:
- advanced case of TFOA (G VI KL scale), which requires total knee replacement.
- flexion deformity ≥15°
- inflammatory disease (such as rheumatoid arthritis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (A)
The patients will undergo open wedge high tibial osteotomy with arthroscopic partial lateral patellar facetectomy.
|
All procedures will be performed based on the technique recommended by the AO international knee expert group.
Biplanar osteotomy, which comprises osteotomies in the axial and frontal planes, will be performed in all cases.
Ascending frontal osteotomy, leaving the tibial tuberosity on the distal fragment, will be also performed.
All osteotomies will be performed without the use of additional bone grafts, and the opening of the osteotomy was maintained with a Tomofix plate (Orthomed-E Co., Egypt).
Wound closure will be performed in layers.
Diagnostic arthroscopy will be performed in all cases to assess Patellofemoral articular cartilage degeneration , assess the lateral compartment and exclude any other pathology.
The knee is taken throughout a range of motion to directly visualize the impingement of the lateral patellar facet against the trochlea.
Next, a radiofrequency probe is used to outline the area to be resected along the lateral patellar facet While maintaining the knee at 20 degrees of flexion, a 5.5-mm burr is introduced, and under arthroscopic visualization, the overhanging portion of the lateral patellar facet is carefully resected.
Once the bony resection is complete, the knee is dynamically re-evaluated (through flexion and extension) for residual impingement and to assess for improvements in patellar mobility.
Patellar tracking is assessed to verify that there is no catching in flexion and that patellar mobility is improved.
|
|
Active Comparator: Group (B)
The patients will undergo open wedge high tibial osteotomy without arthroscopic partial lateral patellar facetectomy.
|
All procedures will be performed based on the technique recommended by the AO international knee expert group.
Biplanar osteotomy, which comprises osteotomies in the axial and frontal planes, will be performed in all cases.
Ascending frontal osteotomy, leaving the tibial tuberosity on the distal fragment, will be also performed.
All osteotomies will be performed without the use of additional bone grafts, and the opening of the osteotomy was maintained with a Tomofix plate (Orthomed-E Co., Egypt).
Wound closure will be performed in layers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: during the follow-up period for 2years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)
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The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100representing no knee problems as common in orthopedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
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during the follow-up period for 2years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)
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Kujala Score (Anterior Knee Pain Scale - AKPS)
Time Frame: during the follow-up period for 2 years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)
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The Kujala Score or Anterior Knee Pain Scale (AKPS) is a 13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome.
The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score.
Lower scores reflect greater pain and disability.
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during the follow-up period for 2 years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kim YM, Joo YB. Patellofemoral osteoarthritis. Knee Surg Relat Res. 2012 Dec;24(4):193-200. doi: 10.5792/ksrr.2012.24.4.193. Epub 2012 Nov 29.
- Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
- Otsuki S, Murakami T, Okamoto Y, Nakagawa K, Okuno N, Wakama H, Neo M. Risk of patella baja after opening-wedge high tibial osteotomy. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018802484. doi: 10.1177/2309499018802484.
- El-Azab H, Glabgly P, Paul J, Imhoff AB, Hinterwimmer S. Patellar height and posterior tibial slope after open- and closed-wedge high tibial osteotomy: a radiological study on 100 patients. Am J Sports Med. 2010 Feb;38(2):323-9. doi: 10.1177/0363546509348050. Epub 2009 Dec 31.
- Loia MC, Vanni S, Rosso F, Bonasia DE, Bruzzone M, Dettoni F, Rossi R. High tibial osteotomy in varus knees: indications and limits. Joints. 2016 Aug 18;4(2):98-110. doi: 10.11138/jts/2016.4.2.098. eCollection 2016 Apr-Jun.
- Iijima H, Fukutani N, Isho T, Yamamoto Y, Hiraoka M, Miyanobu K, Jinnouchi M, Kaneda E, Aoyama T, Kuroki H, Matsuda S. Changes in clinical symptoms and functional disability in patients with coexisting patellofemoral and tibiofemoral osteoarthritis: a 1-year prospective cohort study. BMC Musculoskelet Disord. 2017 Mar 24;18(1):126. doi: 10.1186/s12891-017-1486-4.
- Iijima H, Fukutani N, Aoyama T, Fukumoto T, Uritani D, Kaneda E, Ota K, Kuroki H, Matsuda S. Clinical Impact of Coexisting Patellofemoral Osteoarthritis in Japanese Patients With Medial Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2016 Apr;68(4):493-501. doi: 10.1002/acr.22691.
- Kobayashi S, Pappas E, Fransen M, Refshauge K, Simic M. The prevalence of patellofemoral osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2016 Oct;24(10):1697-1707. doi: 10.1016/j.joca.2016.05.011. Epub 2016 May 14.
- Davies AP, Vince AS, Shepstone L, Donell ST, Glasgow MM. The radiologic prevalence of patellofemoral osteoarthritis. Clin Orthop Relat Res. 2002 Sep;(402):206-12. doi: 10.1097/00003086-200209000-00020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-12---2MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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