Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

Osteoarthritis Knee Clinical Trial

Official title:

Effect of Biomechanical Corrections of Tibia on Medial Joint Space Loading, Varus Deformity and Functional Tasks in Patients With Medial Tibiofemoral Joint Osteoarthritis: A Quasi-Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324931
• Other study ID #: MMDU/IEC/1527
• Secondary ID: U1111-1249-3661
• Status: Completed
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of Biomechanical Correction of Tibia on Medial Joint space loading, Varus deformity and functional tasks in patients with medial tibiofemoral joint osteoarthritis in which participants will be taken. The outcome measures taken are Trauma CAD Software, NPRS, WOMAC and Goniometery will be measured at the baseline after 3rd week of the intervention.

Description:

Background: Knee osteoarthritis (KOA) are very prevalent chronic disease of the joint which causing the functional disability and pain specifically in older adults.

Objective: Purpose of the study is to see that the biomechanical correction on the tibia and varus deformity is effective in the conventional treatment of participants with the KOA.

Study Design: A Randomized single group Pretest-Post test Clinical Trial. Methodology: Total '5' subjects were included in the study with the age of 40 to 60 years based on exclusion and inclusion criteria. For the pain, the NPRS will be taken, goniometer taken for the measurement of range of motion, WOMAC will be taken for the physical activity measurement and CAD Software will be taken to see the alignment of the affected limb. Conventional treatment will also be given.

Conclusion: Biomechanical correction shows the significant improvement and improves the subject's physical activity and reduces the pain and stiffness.

Keywords: Obesity, Osteoarthritis, Pain and Physical therapy modalities

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 31, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria: • 40-60 years of age paients will be included in this study

• BMI (25.1±4.2) kg/m2

• Subjects with stiffness and knee pain

• Subjects with objection of pain in knee joint that was aggravated by performing 2 or more of the following functional activities: prolonged cross sitting, stair assents and descent, squatting and kneeling.

• Subjects who are willing to take participation

• Individuals who obeys the commands properly

• Individuals exhibiting the subsequent biomechanical changes on screening

• Q angle >12 degree for male and >15 degree for female, femoral anteversion, external tibial torsion >15 degree, lack of = 5 degree of knee extension in supine position.

Exclusion Criteria:

• • Knee meniscal injuries or ligament injuries

• Lately history of lower limb trauma and surgery

• In recent times fracture in lower extremity

• In lower extremity metal plantation

• Cardio vascular conditions

• Patella Dislocation/subluxation

• Abnormality in foot or deformity

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Other:
• Biomechanical corrections
Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.
• Conventional Physiotherapy
Conventional therapy includes Hydrocollatoral pack for 20 minutes, Interferential therapy for 15 minutes beat frequency 100 Hz, Sweep frequency 150 Hz and exercise program of 3 sessions for 20 minutes on alternative days for 3 weeks for management of knee osteoarthritis.

Locations

Country	Name	City	State
India	Sunaina Saini	Kurukshetra	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

References & Publications (3)

Crema MD, Felson DT, Guermazi A, Nevitt MC, Niu J, Lynch JA, Marra MD, Torner J, Lewis CE, Roemer FW. Is the atrophic phenotype of tibiofemoral osteoarthritis associated with faster progression of disease? The MOST study. Osteoarthritis Cartilage. 2017 Oc — View Citation

Felson DT, Goggins J, Niu J, Zhang Y, Hunter DJ. The effect of body weight on progression of knee osteoarthritis is dependent on alignment. Arthritis Rheum. 2004 Dec;50(12):3904-9. — View Citation

Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016 Sep;50(5):518-522. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lower limb alignment by Trauma CAD software	Trauma CAD Software will be used to measure the misalignment of the lower limb	Baseline, 3 weeks after intervention
Secondary	Change in pain level by Numeric Pain Rating Scale	This scale will be used for assessment of pain	Baseline, 3 weeks after intervention
Secondary	Change in joint range of motion by Goniometery	Use for range of motion measurement	Baseline, 3 weeks after intervention
Secondary	Change in physical performance	WOMAC will be used for assessment	Baseline, 3 weeks after intervention

External Links

•   Although elevated BMI increases the risk of knee OA progression, the effect of BMI is limited to knees in which moderate malalignment exists, presumably because of the combined focus of load from malalignment and the excess load from increased weight.
•   the atrophic phenotype of knee OA was associated with a decreased likelihood of progression of JSN and cartilage loss compared to the non-atrophic knee OA phenotype.
•   This study has evidenced a large percentage of population as borderline OA; therefore, it depends mainly on the prevention of modifiable risk factors to preserve at ease movement in elderly population through awareness programs.