High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

• Sponsor: Centre of Postgraduate Medical Education (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05128864
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee; Patellofemoral Disorder	Procedure: High Tibial Osteotomy	N/A

Detailed Description

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy
• Actual Study Start Date: Jul 15, 2020
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HTO and Fulkerson High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle	Procedure: High Tibial Osteotomy; Surgery procedure - High Tibial Osteotomy
Sham Comparator: HTO Descending Hight Tibial Osteotomy	Procedure: High Tibial Osteotomy; Surgery procedure - High Tibial Osteotomy

Outcome Measures

Primary Outcome Measures

1. Biomechanics MRI [1 year]

   Patellofemoral Joints Biomechanics improvement measured

2. Biomechanics MRI [2 years]

   Patellofemoral Joints Biomechanics improvement measured

3. Biomechanics X-ray [12 weeks]

   Patellofemoral Joints Biomechanics improvement measured

4. Biomechanics X-ray [6 months]

   Patellofemoral Joints Biomechanics improvement measured

5. Biomechanics X-ray [12 months]

   Patellofemoral Joints Biomechanics improvement measured

6. Biomechanics X-ray [24 months]

   Patellofemoral Joints Biomechanics improvement measured

Secondary Outcome Measures

1. KOOS [12 weeks]

   Knee Injury and Osteoarthritis Outcome Score

2. KOOS [6 months]

   Knee Injury and Osteoarthritis Outcome Score

3. KOOS [12 months]

   Knee Injury and Osteoarthritis Outcome Score

4. KOOS [24 months]

   Knee Injury and Osteoarthritis Outcome Score

5. IKDC [12 weeks]

   International Knee Documentation Committee

6. IKDC [6 months]

   International Knee Documentation Committee

7. IKDC [12 months,]

   International Knee Documentation Committee

8. IKDC [24 months]

   International Knee Documentation Committee

9. Tegner Lysholm [12 weeks,]

   Tegner Lysholm Knee Scoring Scale

10. Tegner Lysholm [6 months]

    Tegner Lysholm Knee Scoring Scale

11. Tegner Lysholm [12 months]

    Tegner Lysholm Knee Scoring Scale

12. Tegner Lysholm [24 months]

    Tegner Lysholm Knee Scoring Scale

13. SF-36 [12 weeks]

    The Short Form (36) Health Survey

14. SF-36 [6 months]

    The Short Form (36) Health Survey

15. SF-36 [12 months]

    The Short Form (36) Health Survey

16. SF-36 [24 months]

    The Short Form (36) Health Survey

17. VAS [12 week]

    Pain Visual Analog Scale

18. VAS [6 months]

    Pain Visual Analog Scale

19. VAS [12 months]

    Pain Visual Analog Scale

20. VAS [24 months]

    Pain Visual Analog Scale

21. Blood test [2nd day]

    CRP, IL-6, CTx

22. Blood test [6 weeks]

    CRP, IL-6, CTx

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination

• Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Exclusion Criteria:

• no informed consent to participate in the study

• age under 18 years or above 65

• multi ligament injury or single plane knee instability

• another musculoskeletal disorders in lower limb

• lower limb deformity requiring axis correction below 4o or above 12.5o

• joints inflammatory diseases

• ASA score > II

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital	Otwock	Mazowieckie	Poland	05-400

Sponsors and Collaborators

• Centre of Postgraduate Medical Education

Investigators

• Principal Investigator: Rafal Kaminski, PCME, Otwock, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rafał Kamiński, Chair of Division, Centre of Postgraduate Medical Education
• ClinicalTrials.gov Identifier: NCT05128864
• Other Study ID Numbers: HTO_fulkerson
• First Posted: Nov 22, 2021
• Last Update Posted: Nov 22, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rafał Kamiński, Chair of Division, Centre of Postgraduate Medical Education: HTO; Fulkerson; Osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 22, 2021