The Effects of Specialized Footwear in Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Effects of Specialized Footwear in Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597830
• Other study ID #: L07041071
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: April 4, 2016
• Start date: July 2007

Study information

• Verified date: April 2016
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Able and willing to give informed consent and to comply with the study protocol and follow-up instructions.

• Symptomatic OA of the knee, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.

• Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC.

• Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.

• Medial compartment OA, defined as either qualitative joint space narrowing of = 1or the presence of medial bone cyst, sclerosis, or osteophyte.

Exclusion Criteria:

• Inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week

• Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.

• Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm at these sites (WOMAC).

• > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).

• Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.

• Concurrent systemic inflammatory arthropathy,

• Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.

• Intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.

• Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.

• Pregnant subjects will be excluded because of the X-rays required.

• Any medical condition that, in the opinion of the PI, would render the subject unable to complete the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Mobility shoe
flat, specialized shoe
• control shoe
control shoe

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Arthritis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Shakoor N, Block JA. Walking barefoot decreases loading on the lower extremity joints in knee osteoarthritis. Arthritis Rheum. 2006 Sep;54(9):2923-7. — View Citation

Shakoor N, Lidtke RH, Sengupta M, Fogg LF, Block JA. Effects of specialized footwear on joint loads in osteoarthritis of the knee. Arthritis Rheum. 2008 Sep 15;59(9):1214-20. doi: 10.1002/art.24017. — View Citation

Shakoor N, Lidtke RH, Wimmer MA, Mikolaitis RA, Foucher KC, Thorp LE, Fogg LF, Block JA. Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Arthritis Rheum. 2013 May;65(5):1282-9. doi: 10.1002/art.37896. — View Citation

Shakoor N, Sengupta M, Foucher KC, Wimmer MA, Fogg LF, Block JA. Effects of common footwear on joint loading in osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jul;62(7):917-23. doi: 10.1002/acr.20165. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic knee loading		6 months to 2 years	No