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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382429
• Other study ID #: chenjinli
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: May 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 20, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• OWHTO
OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.
• CWHTO
CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.

Locations

Country	Name	City	State
China	Jinli Chen	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Baseline
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 6 months
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 12 months
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	Postoperative 18 months
Primary	Radiological evaluation	Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)	Baseline
Primary	Radiological evaluation	Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)	Postoperative 6 months
Primary	Radiological evaluation	Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)	Postoperative 12 months
Primary	Radiological evaluation	Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)	Postoperative 18 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Postoperative complications	Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage	Postoperative 3 day
Secondary	Postoperative complications	Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage	Postoperative 3 months