Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
ID06636136

Transtibial Osseointegration Surgery Study (TOSS)

Led by Walter Reed National Military Medical Center · Updated on 2026-03-30

30

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the OPRA osseointegrated prosthesis system in adults aged 22 to 65 with transtibial (below-the-knee) amputations. The study aims to measure and compare soft tissue complications and infections in patients treated with OPRA implants to those with transfemoral (above-the-knee) implants. It also evaluates improvements in physical function, quality of life, pain levels, physical performance, biomechanical loading, and bone quality over time, comparing OPRA users to traditional socket prosthesis users. Participants undergo two main surgical procedures to implant the OPRA device. In Stage I, the distal tibia is prepared and implanted with the fixture under imaging guidance. Stage II, performed 3 to 6 months later, involves attaching the abutment to the bone and creating a skin opening for prosthesis attachment. Follow-up visits are scheduled post-surgery at 2-3 weeks and then at 6, 12, 24, 36, 48, and 60 months to monitor healing and implant performance. Throughout the study, participants complete various assessments including questionnaires on function, pain, quality of life, and mobility tests such as the 6-Minute Walk Test, Timed Up and Go, and Dual-Energy X-ray Absorptiometry (DEXA) scans. Clinical exams, X-rays, and CT scans are performed regularly to monitor bone and soft tissue status. Data collection occurs at baseline and multiple follow-up points up to 60 months post Stage II surgery, ensuring comprehensive evaluation of safety, function, and patient-reported outcomes.

CONDITIONS

Brief Title

Transtibial Osseointegration

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a transtibial amputation and age between 22 and 65 years.
  • Indicated for the OPRA Implant System due to trauma or cancer with rehabilitation problems or inability to use a conventional socket prosthesis.
  • Failed or expected not to tolerate socket prosthesis due to issues like recurrent skin infections, pain, short stump, volume changes, scarring, extensive skin grafting, perspiration, or limited mobility.
  • Eligible to receive care at the Military Treatment Facility (WRNMMC only).
  • DEERS-eligible (WRNMMC only).
Not Eligible

You will not qualify if you...

  • Incomplete skeletal growth as shown by open epiphyseal zones on X-ray.
  • Atypical skeletal anatomy affecting OPRA treatment, such as deformities, fractures, infections, or abnormal skeletal dimensions.
  • Less than 2 mm of remaining cortex bone around the implant site.
  • Osteoporosis.
  • Age below 22 or above 65 years.
  • Body mass index (BMI) over 35.
  • Severe peripheral vascular disease, diabetic complications, neuropathy, active or dormant infections, metabolic bone disease, or metastatic lesions in residual tibia.
  • Pregnancy before surgery; surgery Stage II delayed if pregnancy occurs after Stage I.
  • Inability to comply with treatment and follow-up.
  • Unable to provide own consent (no legally authorized representative consent allowed).

AI-Screening

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Your Study Journey

Screening

Duration - Up to 6 months prior to Surgery Stage I

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for baseline assessments

Surgery

Duration - Two stages: initial surgery (Stage I) followed by second surgery (Stage II) 3 to 6 months later

Participants undergo two-stage surgical procedures to implant the OPRA device to the amputated leg.

Postoperative visits 2-3 weeks after each surgery

Post-operative Follow-up

Duration - Up to 60 months after Surgery Stage II

Participants are regularly assessed for performance and safety after surgery including questionnaires, physical performance tests, and imaging.

Follow-up visits at 6, 12, 24, 36, 48, and 60 months post-Surgery Stage II

Trial Site Locations

Total: 2 locations

1

Orhopaedic Surgery Service, Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Actively Recruiting

2

Department of Orthopaedic Surgery and Department of Anesthesiology & Critical Care Penn Medicine University City

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Emma L Stewart

Q

Qingfeng Liu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Bone-anchored prostheses in patients with traumatic bilateral transfemoral amputations: rehabilitation description and outcome in 12 cases treated with the OPRA implant system.

Kerstin Hagberg

https://pubmed.ncbi.nlm.nih.gov/29534624

A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients.

R Brånemark, O Berlin, K Hagberg...

https://pubmed.ncbi.nlm.nih.gov/24395320

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

Ruud A Leijendekkers, Gerben van Hinte, Jan Paul Frölke...

https://pubmed.ncbi.nlm.nih.gov/30537856