Quantitatively-informed Socket Design Process

NCT05041998 | Completed

• 2 other identifiers: STUDY20070123W81XWH2010914
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate the effects of specific standardized modifications to trans-femoral prosthetic sockets in a randomized within-subject design. This is in preparation for a subsequently planned clinical trial to validate the findings by implementing them into a fitting method for individual sockets.

Conditions

Artificial Limbs

Outcome Measures

Primary Outcomes (3)

• Residual Femur motion

  medial-lateral and superior-inferior translation of the distal femur relative to the socket from late swing through midstance

  1 second

• Skin strain

  average and peak skin strain within each of four regions, expressed as a percentage of the gait cycle

  1 second

• Socket pressure

  measure peak pressure and area under the pressure versus time curve, expressed as a percentage of the gait cycle

  20 seconds

Secondary Outcomes (8)

• Gait symmetry

  20 seconds

• Plantar pressure

  20 seconds

• Static displacement

  1 second

• Tissue Stiffness

  3 seconds

• Trunk lean

  20 seconds

Study Arms (1)

Unmodified Socket + 8 Socket Modifications in Random Order

EXPERIMENTAL

The sequence of the 9 different interventions (original socket and 8 versions derived from it) is randomized for each participant. The number of participants is smaller than the number of possible permutations. Therefore the enacted ordering is randomly selected from the pool of possible orderings. Participants walk for less than 10 minutes with every socket type while data is being collected.

Device: Trans-femoral prosthetic socket

Interventions

Trans-femoral prosthetic socket DEVICE

Unmodified) A custom-made check socket serving as the interface between residual limb and prosthesis 1. Soft socket (Socket made from softer material than unmodified original) 2. Stiff socket (Socket made from stiffer material than unmodified original) 3. moderately lower brim height (Brim of the socket is lowered by 10% of socket length compared to unmodified original) 4. slightly lower brim height (Brim of the socket is lowered by 5% of socket length compared to unmodified original) 5. Oversized socket (The socket volume is 6% larger than the unmodified original) 6. Undersized socket (The socket volume is 6% smaller than the unmodified original) 7. CAT-CAM influenced geometry (The cross sectional geometry of the socket is modelled following the contoured adducted trochanteric-controlled alignment method (CAT-CAM)) 8. MAS influenced geometry (The cross sectional geometry of the socket is modelled following the Marlo Anatomic Socket (MAS) template)

Unmodified Socket + 8 Socket Modifications in Random Order

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transfemoral prosthesis user
• years of age
• Body weight less than 125 kg
• Able to walk unassisted on a treadmill

You may not qualify if:

• Pregnant females
• Clinically diagnosed osteoporosis
• Previous high exposure to radiation

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Delatorre Orthotics & Prosthetics

Pittsburgh, Pennsylvania, 15328, United States

Location

Related Publications (1)

• Anderst W, Fiedler G, Onishi K, McKernan G, Gale T, Paulus P. Within-subject effects of standardized prosthetic socket modifications on physical function and patient-reported outcomes. Trials. 2022 Apr 12;23(1):299. doi: 10.1186/s13063-022-06205-z.

  PMID: 35413866 DERIVED

Study Officials

• William Anderst, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Research Technician and Engineer will be blinded to the socket modification when processing radiographic data from each trial. The participant will not be told the modification made to each socket, however the nature of the intervention (body worn prosthetic device) makes masking infeasible.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will perform study activities with nine different versions (including the original unmodified) of their prosthetic socket in a randomized sequence.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: August 12, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: upon conclusion of the study (in 2025) with no expiration
• Access Criteria: commensurate with applicable restrictions posed by the study sponsor

Locations

US (2)