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Completed

NCT Number: NCT05382429

Observation of the Clinical Efficacy of Two Surgical Procedures for Varus Knee Osteoarthritis

The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects between two surgical procedures in the treatment of varus knee osteoarthritis.The hypothesis was that there would be no difference in mechanical axis correction between two surgical procedures.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinli Chen

Qingdao, Shandong, 266003, China

About this study

This was a single-center, prospective, double-blinded, randomized controlled trial, comparing two surgical procedures in the treatment of varus knee osteoarthritis. Participants were recruited from September 2019 to September 2021. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia.For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed. For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed. The sample size calculation was based on data from previous studies. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The eligibility criteria for HTO were spontaneous osteonecrosis of the knee of the medial femoral condyle, medial compartment OA, Ahlbäck grades 1 or 2, femorotibial angle (FTA) of ≤185, flexion contracture of ≤15° , lack of damage to the anterior cruciate ligament (ACL) and posterior cruciate ligament, and no age restrictions .

Exclusion criteria

Congenital deformity of knee joint, severe rheumatoid arthritis, Charkoff's joint, injury of knee joint (injury of medial and lateral collateral ligament, patella fracture, etc.) or surgical history (meniscectomy, femoral or tibial fracture after surgery), large number of free bodies or soft tissue flexion contracture in the joint >10º, and range of motion of knee joint <100º.

Treatment and study plan

OWHTO

Procedure

OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.

CWHTO

Procedure

CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.

Primary outcomes

  1. The Visual Analog Scale score

    Time frame: Baseline

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  2. The Visual Analog Scale score

    Time frame: Postoperative 6 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  3. The Visual Analog Scale score

    Time frame: Postoperative 12 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  4. The Visual Analog Scale score

    Time frame: Postoperative 18 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  5. Radiological evaluation

    Time frame: Baseline

    Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)

  6. Radiological evaluation

    Time frame: Postoperative 6 months

    Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)

  7. Radiological evaluation

    Time frame: Postoperative 12 months

    Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)

  8. Radiological evaluation

    Time frame: Postoperative 18 months

    Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)

  9. WOMAC

    Time frame: Baseline

    This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe.

  10. WOMAC

    Time frame: Postoperative 6 months

    This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe.

  11. WOMAC

    Time frame: Postoperative 12 months

    This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe.

  12. WOMAC

    Time frame: Postoperative 18 months

    This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe.

  13. The hospital for surgery score

    Time frame: Baseline

    The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect.

  14. The hospital for surgery score

    Time frame: Postoperative 6 months

    The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect.

  15. The hospital for surgery score

    Time frame: Postoperative 12 months

    The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect.

  16. The hospital for surgery score

    Time frame: Postoperative 18 months

    The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect.

Secondary outcomes

  1. Postoperative complications

    Time frame: Postoperative 3 day

    Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage

  2. Postoperative complications

    Time frame: Postoperative 3 months

    Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Official Title:Observation of the Clinical Efficacy of Two Surgical Procedures on the Short-term Outcome of Moderate Varus Knee Osteoarthritis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 19, 2022
Registry last updated
May 19, 2022

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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