PROMs in Lower Limb Reconstruction

NCT05354960 | Unknown

• 1 other identifier: 2022-00232
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Patient Reported Outcome Measures; Limb Injury; Trauma

Outcome Measures

Primary Outcomes (5)

• LIMB-Q score

  The LIMB-Q is a new questionnaire, which has not yet been validated in German-speaking countries. It contains questions which explicitly refer to the quality of life of patients after trauma to the lower extremity who have undergone either reconstruction or amputation. The question consists of several subscales addressing different domains. Each question within each domain is scored from 1-4, an overall higher scores relates to higher patient satisfaction

  2 years

• Maryland Foot Score (MFS)

  The Maryland Foot Score is a CROM for assessing lower extremity function. Information on pain, gait, functional limitations, aesthetics and mobility are included and scored. The maximum achievable score is 100, which corresponds to an excellent result. Gradations are made from 75-89 points (good), 60-74 points (moderate), \<60 points (poor).

  2 years

• American Orthopedic Foot and Ankle Society Score (AOFAS)

  The AOFAS is a clinical questionnaire that includes information from both the patient and the surgeon. The AOFAS covers four different foot regions: Ankle-Backfoot, Midfoot, Metatarsophalangeal (MTP) - Interphalangeal (IP) for the Hallux, and MTP-IP for the Little Toes. There is a separate version of the AOFAS survey for each of these four anatomical regions. Each is designed to be used independently of the others. However, each measurement consists of nine questions covering three categories: pain (40 items), function (50 items), and alignment (10 items). These are all scored together for a total of 100 points. Higher scores represent better results

  2 years

• Lower Extremity Functional Scale (LEFS)

  The questionnaire contains 20 items that ask about the level of function during daily activities. The questions are answered using a 5-point Likert scale. For evaluation, the sum of the answers is calculated, whereby a maximum score of 80 can be achieved and represents an unrestricted function of the lower extremity.

  2 years

• Short Form- 36 (SF-36)

  The SF-36 is a questionnaire which can be used to assess health-related quality of life. Based on 36 questions, the following qualities are evaluated: general health perception, physical health, limited physical role function, physical pain, vitality, mental health, limited emotional role function, social functioning. The possible score ranges from 0 to 100 points. 0 points represent the greatest possible restriction of health, while 100 points represent the absence of health restrictions.

  2 years

Secondary Outcomes (4)

• Active range of motion

  2 years

• Sensitivity

  2 years

• Circumference

  2 years

• Aesthetic appearance

  2 years

Study Arms (1)

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.

Other: Questionnaire validation

Interventions

Questionnaire validation OTHER

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

Validation of LIMB-Q questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients after reconstructive surgery and/or amputation of the lower extremity of the Department of Plastic Surgery and Hand Surgery, University Hospital Zurich, Switzerland

You may qualify if:

• 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.

You may not qualify if:

• Patients with a tumor disease affecting the lower extremity.

Sponsors & Collaborators

• Nicole Lindenblatt: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (14)

• 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.

  PMID: 30625504 BACKGROUND

• 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.

  PMID: 30551728 BACKGROUND

• 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.

  PMID: 31333950 BACKGROUND

• 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.

  PMID: 27687325 BACKGROUND

• 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.

  PMID: 3068365 BACKGROUND

• 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

  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.

  PMID: 31625944 BACKGROUND

• 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.

  PMID: 32615610 BACKGROUND

• 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.

  PMID: 27725792 BACKGROUND

• 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.

  PMID: 27913260 BACKGROUND

• 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.

  PMID: 25256899 BACKGROUND

• 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.

  PMID: 17144955 BACKGROUND

• 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.

  PMID: 10201543 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Nicole Lindenblatt, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 2, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: November 30, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After statistical analysis
• Access Criteria: Patient data will be shared after enryption and statistical analysis

Locations

CH (1)