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Understanding the biomechanics of below the knee prosthetic socket fit: comparing pressure cast and traditional patella tendon bearing techniques

Understanding the biomechanics of transtibial socket fit: comparing pressure cast and traditional patella tendon bearing techniques

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001399280
Enrollment
10
Registered
2018-08-20
Start date
2018-09-03
Completion date
2018-12-03
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Conventional PTB transtibial prosthetic sockets are widely-used throughout the developing world, however, the manufacture of PTB sockets is still highly dependent on the skill and experience of the attending prosthetist. A PCAST technique for the manufacture of transtibial sockets has been shown to be a potential alternative to PTB sockets, with similar initial patient outcomes recorded for the two sockets. The PTB socket is formed by deliberately creating regions of loading corresponding with the perceived pressure tolerant and intolerant areas of the residual limb. Although, pressure cast sockets aim to load the residual limb more uniformly, eliminating regions of high pressure; previous studies have shown this does not occur. In the PTB socket, the anterior aspect of the socket is shaped closely around either side of the tibial ridge providing rotational stability of the limb. Given the PCAST does not feature this shaping, it is hypothesised that the wearer makes a number of musculo-skeletal adaptations in order to walk stably. Previous comparisons of the PCAST and PTB sockets have explored the space and time characteristics of gait and subjective comfort levels of the wearers. All previously performed tests have involved level walking at self-selected comfortable or fast pace. No studies to date have examined the musculoskeletal gait adaptations of wearers of pressure-cast sockets, or the relationships between the gait biomechanics and the resultant loading patterns in the socket. Thus, further research is required to investigate through what mechanisms or biomechanical adaptations these fundamentally different sockets achieve similar patient outcomes, and how these adaptations change when walking on a non-level surface. Historically, load bearing hydrocasting techniques have been performed with the patient standing with either with 50% of their body weight supported by the pressurised liquid, or during full weight bearing. Intuitively, the rationale for each of these loading conditions is that the loading condition during casting reflects the limb loading during stance and the single support phase of gait respectively. However, there is no empirical data to suggest the either method leads to superior fit, gait biomechanics or comfort. Nor is there any data to quantify the volume, geometry or alignment requirements of the sockets manufactured using the differing hydrocast loading conditions. An understanding of the aforementioned will allow the refinement and potentially improved consistency of hydrocasting techniques among researchers.

Interventions

Intervention Name: Pressure cast (PCAST) Prosthetic Socket A Caulfield hospital staff member with International Society for Prosthetics and Orthotics (ISPO) category I qualifications will cast, fabricate and fit the PCAST sockets. Briefly, the PCAST technique involves wrapping participants’ residual limb, wearing a cotton sock, in plaster wrap uniformly; followed by placement of the limb into the PCAST tank (made of polyvinyl chloride) filled with water, separated from the limb by a polyethelene

Intervention Name: Pressure cast (PCAST) Prosthetic Socket A Caulfield hospital staff member with International Society for Prosthetics and Orthotics (ISPO) category I qualifications will cast, fabricate and fit the PCAST sockets. Briefly, the PCAST technique involves wrapping participants’ residual limb, wearing a cotton sock, in plaster wrap uniformly; followed by placement of the limb into the PCAST tank (made of polyvinyl chloride) filled with water, separated from the limb by a polyethelene diaphragm. The water pressure is increased until the participants can stand with a portion of their weight supported by the pressurised water. Once the plaster wrap hardens, the tank is depressurised and the plaster removed. No rectifications to the positive socket mould based on the plaster wrap are performed with the exception of the smoothing of obvious rough edges. Participants will be fit with two versions of the PCAST socket: one with 50% of their weight supported by the residual limb during casting, and one with ~85% of their weight supported by the residual limb during casting. Participants will also be cast with a traditional Patella tendon bearing (PTB) socket using standard techniques, described elsewhere. The casting and initial fitting of the prosthetic socket will take approximately 2 hours. The study will take place at the Royal Melbourne Hospital and the University of Melbourne. The hard sockets will be manufactured using standard techniques and the prosthetic limbs comprised standard modular components and a multi-articulating foot. The sockets will only be worn during the data collection periods, hence no adherence to socket wearing is required. At the beginning of each data collection session, the participants will undergo 15 minutes acclimatisation walking with the socket and test prostheses prior to data collection. Following data collection with one socket type, the participants will be given a rest period of approximately 10 minutes during which they will sit with their own prostheses donned, prior to data collection with the next socket type.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Eligibility requirements dictate that participants o had unilateral transtibial amputations, caused by trauma, osteosarcoma or congenital defects o were adults, between the ages of 18 and 40 with no compounding co-morbidities which negatively affect their stability or mobility. o require no aids additional to their prosthetic limb for mobility o were established and frequent users of their prosthetics o were community ambulators, with Medicare functional levels K3 or K4

Exclusion criteria

o compounding co-morbidities which negatively affect their stability or mobility. o required aids additional to their prosthetic limb for mobility

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026