High Tibial Osteotomy With/Without Arthroscopy.

• Sponsor: Centre of Postgraduate Medical Education (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05128851
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee; Meniscus; Degeneration	Procedure: HTO; Procedure: Arthroscopy treatment; Procedure: Micro fractures	N/A

Detailed Description

Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 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 Arthroscopic Treatment of Knee Intraarticular Lesions.
• 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: High Tibial Osteotomy and arthroscopy High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.	Procedure: HTO; Hight Tibial Osteotomy; Procedure: Arthroscopy treatment; Arthroscopy treatment
Sham Comparator: High Tibial Osteotomy Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.	Procedure: HTO; Hight Tibial Osteotomy
Active Comparator: High Tibial Osteotomy, arthroscopy and microfractures High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.	Procedure: HTO; Hight Tibial Osteotomy; Procedure: Arthroscopy treatment; Arthroscopy treatment; Procedure: Micro fractures; Micro fractures

Outcome Measures

Primary Outcome Measures

1. KOOS [12 months]

   Knee Injury and Osteoarthritis Outcome Score

2. KOOS [24 months]

   Knee Injury and Osteoarthritis Outcome Score

3. IKDC [12 months]

   International Knee Documentation Committee - Subjective Knee Evaluation Form

4. IKDC [24 months]

   International Knee Documentation Committee - Subjective Knee Evaluation Form

5. VAS [12 months]

   Visual Analog Scale

6. VAS [24 months]

   Visual Analog Scale

7. Blood test [2 day]

   no inflammatory reaction - CRP, Il-6, CTx

8. Blood test [6 weeks]

   no inflammatory reaction - CRP, Il-6, CTx

9. Blood test [12 weeks,]

   no inflammatory reaction - CRP, Il-6, CTx

Secondary Outcome Measures

1. Kinematic MRI with [chondrogram] [2 day,]

   Meniscus healing, cartilage quality

2. Kinematic MRI with [chondrogram] [24 months]

   Meniscus healing, cartilage quality

3. X-ray - Baldini projection [2 day]

   Patellofemoral joint measurements

4. X-ray - Baldini projection [24 months]

   Patellofemoral joint measurements

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

• Intraarticular lesions in MRI

• 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

• multilligament 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, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital	Otwock	Mazowieckie	Poland	05-400

Sponsors and Collaborators

• Centre of Postgraduate Medical Education

Investigators

• Principal Investigator: Rafał Kamiński, 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: NCT05128851
• Other Study ID Numbers: HTO_artro
• 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; Degenerative Meniscus; Osteoarthritis; Microfracture
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 22, 2021