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NCT Number: NCT06762171

Management of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis

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

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Sohag university

Sohag, Sohag Governorate, Egypt

Location status: Recruiting

Location contact

Moustafa Ismail, Assistant Professor

CONTACT

[email protected]

01003142740

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Open Wedge High Tibial Osteotomy

Procedure

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 facetectomy

Procedure

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.

Primary outcomes

  1. 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 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.

  2. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Tarek Ahmed, Assistant lecturer

CONTACT

[email protected]

01033667677

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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