Management of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis

NCT06762171 | Recruiting

• 1 other identifier: Soh-Med-24-12---2MD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

The patients will undergo open wedge high tibial osteotomy with arthroscopic partial lateral patellar facetectomy.

Procedure: open wedge high tibial osteotomy; Procedure: Arthroscopic partial lateral patellar facetectomy

Group (B)

ACTIVE COMPARATOR

The patients will undergo open wedge high tibial osteotomy without arthroscopic partial lateral patellar facetectomy.

Procedure: open wedge high tibial osteotomy

Interventions

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.

Group (A); Group (B)

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.

Group (A)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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°

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine, Sohag university

Sohag, Sohag Governorate, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 30295136 BACKGROUND

• 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.

  PMID: 20044496 BACKGROUND

• 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.

  PMID: 27602350 BACKGROUND

• 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.

  PMID: 28340623 BACKGROUND

• 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.

  PMID: 26315986 BACKGROUND

• 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.

  PMID: 23269956 BACKGROUND

• 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.

  PMID: 27188684 BACKGROUND

• 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.

  PMID: 2302884 BACKGROUND

• 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.

  PMID: 12218486 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Ahmed Tarek Ahmed, Assistant lecturer

CONTACT

01033667677; Ahmed.Tarek@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Orthopaedic and Traumatology, Faculty of medicine, Sohag university

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 7, 2025
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)