PROMs in Lower Limb Reconstruction

NCT ID: NCT05354960

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-11-30

Brief Summary

The purpose of the study is to evaluate the validity of PROMS after reconstructive surgery or amputation in the leg region. In this context, the German version of the LIMB-Q, a questionnaire-based "Patient-reported outcome measurement" (PROM), will be validated for the German-speaking region and any necessary cultural adaptations will be made for the future use of the questionnaire.

In addition, the aim is to establish a context between the LIMB-Q as a PROM and clinical outcome measurements (Maryland Foot Score, American Orthopedic Foot and Ankle Society Score).

Detailed Description

Complex tissue loss in the lower extremities is often a clinical challenge. Many different factors must be considered and weighted in the treatment algorithm, with functional restoration of the leg remaining the primary goal. Surgeon assessment alone is not sufficient to fully describe treatment outcomes. Different outcome measurement tools have been used in the past in an attempt to eval-uate these complex issues. Surgical outcomes that focus on complications and function from the physician's perspective provide valuable information but do not give a complete picture. Therefore, as in other areas of healthcare, patient-reported outcomes have become an integral part of as-sessing the quality and effectiveness of the services provided. Only a combination of clinicians' and patients' perspectives can contribute to obtaining a conclusive picture of the services provided. However, no validated patient reported outcome measure (PROM) instrument exists to date. Lower extremity injuries are life-changing events for patients. While approximately 70% undergo recon-struction, there are currently 200,0000 individuals in the United States living with a lower extremity amputation secondary to trauma. There is currently no PRO instrument in use for patients with limb-threatening lower extremity injuries. Instead, commonly used PRO instruments include the Musculoskeletal Tumor Society and the "Toronto Extremity Salvage Score", both designed for use in musculoskeletal oncology, as well as the Western Ontario and McMaster University Osteoar-thritis Index, designed for arthritis patients". These measures are limited, as they were not de-signed using qualitative interview data of patients with limb-threatening lower extremity traumatic injuries. They therefore, have not proven to be reflective of the important COI relevant to this pa-tient population. PRO instruments focusing on patients who have undergone amputation only are also in use, such as the Trinity Amputation and Prosthesis Experience Scales. However, there is no PRO instrument that is designed for all patients with limb-threatening lower extremity traumatic injuries that measures COI relevant to both reconstruction and amputation patient groups.

PRO instruments designed specifically for a given disease process are important, as they measure concepts such as satisfaction with appearance, body image, function, mobility, and psychosocial wellbeing, providing meaningful, precise, and reliable feedback on important patient- centered out-comes relevant to a specific patient population. This will allow meaningful, precise and reliable feedback on important patient-centered outcomes, with the potential for widespread use in clinical audit for quality improvement, and local, national and international research efforts.

In clinical research the LIMB-Q will have the capability to measure differences in outcomes im-portant to patients, allowing it to compare different treatments for severe lower extremity trauma. While substantial research has focused on identifying the "superior" treatment method between re-construction and amputation, this PRO instrument will be the first research instrument to allow this question to be asked while taking into account COI important to patients. In clinical care the it will provide patients with a structured and reliable method of communicating outcomes to providers, allowing for real-time adjustments in care to improve overall results.

The preliminary LIMB-Q scales have been developed using international standards for PRO in-strument development. Briefly, semi-structured qualitative interviews, combined with expert opin-ion and a literature review were used to generate a conceptual framework and preliminary set of scales. Next, cognitive debriefing interviews and solicitation of expert opinion were performed to further refine the preliminary instrument for clarity and comprehensiveness of content. The prelimi-nary LIMB-Q scales is now undergoing a large-scale, multi-institutional field test..

A comparison of outcomes assessment shows that surgeons tend to overestimate outcomes com-pared with patients. CROMs are well accepted by patients and have a high reliability. It is argued that PROM results are more difficult to interpret than objective CROMs due to higher inter- and intra-observer variability and subjective PROM assessment for cultural and other individual rea-sons. Thus, it is important to establish a context between already established CROMs and PROMs.

The purpose of the study is to evaluate the validity of PROMS after reconstructive surgery or am-putation of the legs due to trauma. The aim of the study is to validate the German version of the LIMB-Q, a questionnaire-based patient-reported outcome measurement (PROM) for the German-speaking region and to make any necessary cultural adaptations for the future use of the question-naire in order to be able to utilize the LIMB-Q in the future for all affected patients who receive re-constructive surgery or amputation of the lower extremity in the context of trauma in order to gain a better understanding of factors that have an influence on patient satisfaction. Furthermore, a con-text between the LIMB-Q as PROM and clinical outcome measures (CROMs) will be established.

Conditions

Patient Reported Outcome Measures; Limb Injury; Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Validation of LIMB-Q questionnaire

We plan to validate the questionnaires for quality of life and functional impairment in a mixed study population. In addition, CROMs, specifically the active range of motion, the 2 PD, compara-tive circumference measurements, AOFAS and MFS will be collected. In addition, photo documen-tation of the operated lower extremity will be performed. The results obtained will be correlated with each other.

Questionnaire validation

Intervention Type: OTHER

Validation and cultural adaption of the German version of the LIMB-Q

Interventions

Questionnaire validation

Validation and cultural adaption of the German version of the LIMB-Q

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female patients after lower extremity reconstructive surgery aged 18 years or older
• Male and female patients aged 18 years or older who have received /suffered a lower extremity amputation in the past.
• Written informed consent from the participating individual.

Exclusion Criteria

• Patients with a tumor disease affecting the lower extremity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicole Lindenblatt

OTHER

Sponsor Role: lead

Responsible Party

Nicole Lindenblatt

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicole Lindenblatt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Facility Contacts

Inga S Besmens, MD

Role: primary

inga.besmens@usz.ch

+41 44 255 1111

Jennifer A Watson, MD

Role: backup

jenniferashley.watson@usz.ch

+41 44 255 1111

References

Heidekrueger PI, Ehrl D, Prantl L, Thiha A, Weinschenk F, Forte AJ, Ninkovic M, Broer PN. Microsurgical Reconstruction of the Plantar Foot: Long-Term Functional Outcomes and Quality of Life. J Reconstr Microsurg. 2019 Jun;35(5):379-388. doi: 10.1055/s-0038-1677038. Epub 2019 Jan 9.

Reference Type: BACKGROUND

PMID: 30625504 (View on PubMed)

Kash BA, McKahan M, Tomaszewski L, McMaughan D. The four Ps of patient experience: A new strategic framework informed by theory and practice. Health Mark Q. 2018 Oct-Dec;35(4):313-325. doi: 10.1080/07359683.2018.1524598. Epub 2018 Dec 14.

Reference Type: BACKGROUND

PMID: 30551728 (View on PubMed)

Mundy LR, Grier AJ, Weissler EH, Carty MJ, Pusic AL, Hollenbeck ST, Gage MJ. Patient-reported Outcome Instruments in Lower Extremity Trauma: A Systematic Review of the Literature. Plast Reconstr Surg Glob Open. 2019 May 3;7(5):e2218. doi: 10.1097/GOX.0000000000002218. eCollection 2019 May.

Reference Type: BACKGROUND

PMID: 31333950 (View on PubMed)

Davis LA, Dandachli F, Turcotte R, Steinmetz OK. Limb-sparing surgery with vascular reconstruction for malignant lower extremity soft tissue sarcoma. J Vasc Surg. 2017 Jan;65(1):151-156. doi: 10.1016/j.jvs.2016.05.094. Epub 2016 Sep 26.

Reference Type: BACKGROUND

PMID: 27687325 (View on PubMed)

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

Reference Type: BACKGROUND

PMID: 3068365 (View on PubMed)

Gallagher P, MacLachlan M. Development and psychometric evaluation of the Trinity Amputation and Prosthesis Experience Scales (TAPES). Rehabil Psychol. 2000;45(2):130-154. doi:10.1037/0090-5550.45.2.130

Reference Type: BACKGROUND

Mundy LR, Klassen A, Grier J, Carty MJ, Pusic AL, Hollenbeck ST, Gage MJ. Development of a Patient-Reported Outcome Instrument for Patients With Severe Lower Extremity Trauma (LIMB-Q): Protocol for a Multiphase Mixed Methods Study. JMIR Res Protoc. 2019 Oct 17;8(10):e14397. doi: 10.2196/14397.

Reference Type: BACKGROUND

PMID: 31625944 (View on PubMed)

Mundy LR, Klassen A, Sergesketter AR, Grier AJ, Carty MJ, Hollenbeck ST, Pusic AL, Gage MJ. Content Validity of the LIMB-Q: A Patient-Reported Outcome Instrument for Lower Extremity Trauma Patients. J Reconstr Microsurg. 2020 Nov;36(9):625-633. doi: 10.1055/s-0040-1713669. Epub 2020 Jul 2.

Reference Type: BACKGROUND

PMID: 32615610 (View on PubMed)

Janssen SJ, van Rein EA, Paulino Pereira NR, Raskin KA, Ferrone ML, Hornicek FJ, Lozano-Calderon SA, Schwab JH. The Discrepancy between Patient and Clinician Reported Function in Extremity Bone Metastases. Sarcoma. 2016;2016:1014248. doi: 10.1155/2016/1014248. Epub 2016 Sep 20.

Reference Type: BACKGROUND

PMID: 27725792 (View on PubMed)

Joswig H, Stienen MN, Smoll NR, Corniola MV, Chau I, Schaller K, Hildebrandt G, Gautschi OP. Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease. World Neurosurg. 2017 Mar;99:26-30. doi: 10.1016/j.wneu.2016.11.039. Epub 2016 Nov 29.

Reference Type: BACKGROUND

PMID: 27913260 (View on PubMed)

Gautschi OP, Corniola MV, Schaller K, Smoll NR, Stienen MN. The need for an objective outcome measurement in spine surgery--the timed-up-and-go test. Spine J. 2014 Oct 1;14(10):2521-2. doi: 10.1016/j.spinee.2014.05.004. No abstract available.

Reference Type: BACKGROUND

PMID: 25256899 (View on PubMed)

SooHoo NF, Vyas R, Samimi D. Responsiveness of the foot function index, AOFAS clinical rating systems, and SF-36 after foot and ankle surgery. Foot Ankle Int. 2006 Nov;27(11):930-4. doi: 10.1177/107110070602701111.

Reference Type: BACKGROUND

PMID: 17144955 (View on PubMed)

Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

Reference Type: BACKGROUND

PMID: 10201543 (View on PubMed)

Maryland Foot Score. J Orthop Trauma. 2006;20(8). https://journals.lww.com/jorthotrauma/Fulltext/2006/09001/Maryland_Foot_Score.22.as

Reference Type: BACKGROUND

Other Identifiers

2022-00232

Identifier Type: -

Identifier Source: org_study_id