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

NCT05382429 | Completed

• 1 other identifier: chenjinli
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; high tibial osteotomy; medial collateral ligament; fracture healing

Outcome Measures

Primary Outcomes (16)

• The Visual Analog Scale score

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

  Baseline

• The Visual Analog Scale score

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

  Postoperative 6 months

• The Visual Analog Scale score

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

  Postoperative 12 months

• The Visual Analog Scale score

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

  Postoperative 18 months

• Radiological evaluation

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

  Baseline

• Radiological evaluation

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

  Postoperative 6 months

• Radiological evaluation

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

  Postoperative 12 months

• Radiological evaluation

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

  Postoperative 18 months

• WOMAC

  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.

  Baseline

• WOMAC

  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.

  Postoperative 6 months

• WOMAC

  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.

  Postoperative 12 months

• WOMAC

  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.

  Postoperative 18 months

• The hospital for surgery score

  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.

  Baseline

• The hospital for surgery score

  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.

  Postoperative 6 months

• The hospital for surgery score

  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.

  Postoperative 12 months

• The hospital for surgery score

  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.

  Postoperative 18 months

Secondary Outcomes (2)

• Postoperative complications

  Postoperative 3 day

• Postoperative complications

  Postoperative 3 months

Study Arms (2)

OWHTO

EXPERIMENTAL

open wedge high tibial osteotomy group For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed.

Procedure: OWHTO

CWHTO

EXPERIMENTAL

closing wedge high tibial osteotomy group For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed

Procedure: CWHTO

Interventions

OWHTO PROCEDURE

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

OWHTO

CWHTO PROCEDURE

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

CWHTO

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Jinli Chen

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. According to preoperative allocation, the patients were given open wedge high tibial osteotomy or closingwedge high tibial osteotomy.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.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 20, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to lichunpu2020@163.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website .

Locations

CN (1)