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Helping patients and physicians choose the appropriate surgery for end stage hallux rigidus

Award Number: R01AR078487
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/16/2021
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Helping patients and physicians choose the appropriate surgery for end stage hallux rigidus - Project Summary/Abstract The primary objective of this project is to obtain observational data necessary to design a future clinical trial comparing arthrodesis to motion sparing surgery in patients with hallux rigidus (HR). HR is a degenerative disease of the first metatarsophalangeal joint (MTPJ1). It is the most common form of arthritis in the foot, affecting 1 in 40 people over the age of 50 with a 2:1 ratio of females to males. The MTPJ1 plays a critical functional role in walking as it carries approximately 119% of an individual's body weight with each step; therefore, the joint pain and loss of motion lead to a significant reduction in activity and quality of life for patients. HR is typically treated by modifications to or within the shoe combined with modifications of activity and NSAIDs. When these treatments are not effective, surgery may be performed. Arthrodesis (fusion) is an effective measure for pain control but eliminates motion at the joint leading to limited footwear options which can have a major impact on women, in particular, who wear shoes of varying levels of heel elevation. These limitations have driven patients to seek alternatives that spare MTPJ1 motion. Early promising results have intensified the debate over fusion versus joint sparing, but their comparative safety and efficacy is not established. Multiple joint sparing procedures include (1) various arthroplasties, (2) cheilectomy with or without osteotomy, and (3) a synthetic cartilage implant. These more modern techniques have not been compared with arthrodesis with the exception of one non-inferiority trial comparing a synthetic cartilage implant to arthrodesis which reported similar results for pain and function and implant failures after 2 years. There are no comparative trials evaluating cheilectomy. Arthroplasties including synthetic implants increase treatment costs but preserve motion. Therefore, there is a strong demand to determine if motion sparing is equally or more effective compared to arthrodesis in outcomes important to patients. The proposed observational study (and subsequent U01 trial) is intended to overcome the specific gaps in the literature and obstacles to designing a future trial including: (1) using observational data from several centers that employ multiple motion sparing procedures and arthrodesis to determine if there are appreciable differences that will require a single arm or multiple motion sparing treatment arms compared to fusion in a future trial, (2) identifying correlates of HR disease severity using an expert panel with exploratory data analysis of the observational data to begin the important process of developing and validating a novel HR classification system, (3) performing qualitative interviews of existing pilot study patients at various time points in the follow-up process to ascertain what outcomes are most important to them so that we can ensure the outcomes we include in the future trial match these preferences (for male and female should they differ), and (4) designing and planning a randomized controlled trial or a future U01 grant.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$11,831 )
2026	2023	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY	SEATTLE	WA	98108	KING	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	2/25/2026	NON-COMPETING CONTINUATION	-$11,831
														Subtotal = -$11,831

Issue Date FY: 2023 ( Subtotal = $119,856 )
2023	2023	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY	SEATTLE	WA	98108	KING	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	6/14/2023	NON-COMPETING CONTINUATION	$119,856
														Subtotal = $119,856

Issue Date FY: 2022 ( Subtotal = $207,651 )
2022	2022	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	6/29/2022	NON-COMPETING CONTINUATION	$207,651
														Subtotal = $207,651

Issue Date FY: 2021 ( Subtotal = $209,748 )
2021	2021	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/16/2021	NEW	$209,748
2021	2021	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	1	8/2/2021	NEW	$0
														Subtotal = $209,748

Grand Total All Awards = $525,424

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Helping patients and physicians choose the appropriate surgery for end stage hallux rigidus

Award Number: R01AR078487

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/16/2021

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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