AzTrials
AzTrials

Knee OsteoarthritisNCT06762171

Management of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis

A study testing open wedge high tibial osteotomy and Arthroscopic partial lateral patellar facetectomy in people with Knee Osteoarthritis, run by Sohag University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Evaluate the results of management of patients with patellofemoral and medial compartment knee osteoarthritis with open wedge high tibial osteotomy with or without arthroscopic partial lateral patellar facetectomy Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
open wedge high tibial osteotomy and Arthroscopic partial lateral patellar facetectomy
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 Dec 2024to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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°

Who cannot join

  • advanced case of TFOA (G VI KL scale), which requires total knee replacement.
  • flexion deformity ≥15°
  • inflammatory disease (such as rheumatoid arthritis).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Tarek Ahmed, Assistant lecturer contact

01033667677

Ahmed.Tarek@med.sohag.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of medicine, Sohag university

    Sohag, Sohag Governorate

    Moustafa Ismail, Assistant Professor, 01003142740, mostafa.ismael79@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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

Evaluate the results of management of patients with patellofemoral and medial compartment knee osteoarthritis with open wedge high tibial osteotomy with or without arthroscopic partial lateral patellar facetectomy

Read the 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.

Being tested
open wedge high tibial osteotomy, Arthroscopic partial lateral patellar facetectomy
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open wedge high tibial osteotomyProcedure or surgery

    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.

  • Arthroscopic partial lateral patellar facetectomyProcedure or surgery

    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.

Study groups in NCT06762171
Study groupRoleWhat they receive
Group (A)Active comparatorThe patients will undergo open wedge high tibial osteotomy with arthroscopic partial lateral patellar facetectomy.
Receives: Procedure: open wedge high tibial osteotomy; Procedure: Arthroscopic partial lateral patellar facetectomy
Group (B)Active comparatorThe patients will undergo open wedge high tibial osteotomy without arthroscopic partial lateral patellar facetectomy.
Receives: Procedure: open wedge high tibial osteotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    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.

    Measured: during the follow-up period for 2years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)

  2. Kujala Score (Anterior Knee Pain Scale - AKPS)

    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.

    Measured: during the follow-up period for 2 years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start1 Dec 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06762171
Sponsor's protocol ID
Soh-Med-24-12---2MD
Status last verified
Dec 2024
First submitted
22 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30295136
  • 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.

    PubMed 20044496
  • 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.

    PubMed 27602350
  • 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.

    PubMed 28340623
  • 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.

    PubMed 26315986
  • 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.

    PubMed 23269956
  • 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.

    PubMed 27188684
  • 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.

    PubMed 2302884
  • 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.

    PubMed 12218486

Questions about this trial

What is this clinical trial studying?

A study testing open wedge high tibial osteotomy and Arthroscopic partial lateral patellar facetectomy in people with Knee Osteoarthritis, run by Sohag 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?

The sponsor lists 7 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Tarek Ahmed, Assistant lecturer (01033667677, Ahmed.Tarek@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. 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 NCT06762171, which also lists 9 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 7 Jan 2025.

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