Transtibial Osseointegration

NCT06636136 | Recruiting DMC FDA Device

• 1 other identifier: WRNMMC-2023-0445
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members. Aim 2: Compare the validated domains, such as functional, quality of life and pain scores, from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements. Aim 3: Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements. Aim 4: Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration. Aim 5: Compare outcome measures between persons with traditional socket prostheses (patients as self-controls) and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI. Subject Population: Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss. Study Design: This is a 4-year, prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation. Procedures: SURGICAL PROCEDURES: Surgery Stage I: The distal part of the tibia is exposed, preferably using existing incisions, to produce an appropriate fasciocutaneous flap. By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found. The canal is reamed step by step to a proper diameter to facilitate insertion of the implant. If the bone quality is poor, as determined by the operating surgeon, autologous bone graft from the iliac crest and/or the medullary canal is used. The fixture is then implanted into the intramedullary canal. Careful surgical technique is essential not to damage the tissue and to achieve osseointegration. A central screw, healing cylinder, and healing bolt are inserted. A myodesis is performed, and the wound is closed using suture. The sutures are removed 2-3 weeks postoperatively. When the skin is completely healed the Patient's conventional socket prosthesis could, in some instances, be used. Surgery Stage II (3-5 months after Stage I): The tibia is exposed via the incision from the Stage I-Surgery. The healing cylinder is removed and the tissues are trimmed in a way that the distal end of the bone protrudes a few millimeters. The skin will be attached directly to it. The endosteal canal is reamed to facilitate placement of the abutment. The skin in the abutment area is then trimmed to a diameter equal to the protruding end of the tibia. This is done to remove the subcutaneous fat and facilitate healing of the dermal layer to the distal end of the bone. The subcutaneous tissue is affixed to the periosteum using absorbable suture to prevent skin movement. A 8mm punch biopsy tool is used to create a circular hole in the skin precisely over the residual tibial canal. The remaining portion of the fasciocutaneous flap is sutured into position. A bolster dressing is placed and routine postoperative wound care is performed by daily dressing changes. Sutures are removed 2-3 weeks postoperatively. CLINICAL PROCEDURES A pre-study visit will be conducted up to 6 months prior to Surgery Stage I. Postoperative visits will occur 2-3 weeks after each surgery. Additional follow-up visits will occur 6, 12, 24, 36, 48 and 60 months post-Surgery Stage II. It is standard of care to follow patients postoperatively from time to time to ensure the wound(s) is /are healing, surveil for complications, and ensure rehabilitation is progressing. That said, the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol. Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical status/bone healing. RESEARCH PROCEDURES Timepoints: Baseline, Post-Op Stage II, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months The patients will be assessed before and after the surgery regularly. Both performance and safety data will be recorded on specially designed electronic Case Report Forms (eCRFs). Clinical and radiological assessments are performed preoperatively (in connection with the surgical procedures.

Conditions

Amputation; Traumatic, Leg, Lower

Keywords

Transtibial; Osseointegration

Outcome Measures

Primary Outcomes (5)

• Quantify soft tissue complications of participants with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service participants

  Collecting the rate of complications after the surgery

  60 months post-surgery stage II.

• Compare the validated domains: functional from the preoperative baseline to follow-up visits

  The participants reported outcome measurement system: Questionnaire · To evaluate "before and after surgery" changes in functional status

  60 months post-surgery stage II.

• Quantify soft tissue infections of participants with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service participants

  Collecting the rate of infections after the surgery

  60 months post-surgery stage II.

• Compare the validated domains: quality of life from the preoperative baseline to follow-up visits

  The participants reported outcome measurement system: Questionnaire · To evaluate "before and after surgery" changes in quality of life

  60 months post-surgery stage II.

• Compare the validated domains: pain scores from the preoperative baseline to follow-up visits

  The participants reported outcome measurement system: Questionnaire · To evaluate "before and after surgery" changes in pain

  60 months post-surgery stage II.

Secondary Outcomes (8)

• Compare physical performance measures ( changes in residual limb confidence ) preoperatively to follow-up visits for persons within transtibial amputations treated with OPRA osseointegrated prostheses

  60 months post-surgery stage II.

• Quantify the biomechanical loading changes that are directly associated with patient-reported outcomes for persons with transtibial amputations treated with OPRA osseointegration.

  60 months post-surgery stage II.

• Compare outcome measures between persons with traditional socket prostheses (patients as self-controls) and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI.

  60 months post-surgery stage II.

• Compare physical performance measures (in functional muscle strength) preoperatively to follow-up visits for persons within transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant

  60 months post-surgery stage II.

• Compare physical performance measures (changes in physical mobility) preoperatively to follow-up visits for persons within transtibial amputations treated with OPRA osseointegrated prostheses

  60 months post-surgery stage II.

Study Arms (1)

OPRA implant leg

OTHER

The participants will have two stage surgical procedures to implant the OPRA device to the amputated leg.

Device: OPRA

Interventions

OPRA DEVICE

Surgery

OPRA implant leg

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a transtibial amputation age 22-65.
• The OPRA™ Implant System is indicated for patients who have transtibial amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA™ Implant System is intended for skeletally mature patients.
• The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:
• Recurrent skin infections and ulcerations in the socket contact area
• Pain
• A short stump preventing the use of socket prosthesis
• Volume fluctuation in the stump
• Soft tissue scarring
• Extensive area of skin grafting
• Socket retention problems due to excessive perspiration
• Restricted mobility
• Eligible to receive care at Military Treatment Facility ( WRNMMC only)
• DEERS-eligible ( WRNMMC only)

You may not qualify if:

• The patient's skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.
• The patient has atypical skeletal anatomy which may affect treatment with OPRA™.
• Examples of atypical skeletal anatomy.
• Skeletal dimensions outside defined interval.
• Development anomalies.
• Conditions which are not amenable to device insertion such as deformities, fracture, infection.
• The patient would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
• Osteoporosis.
• The patient is older than 65 years and younger than 22 years.
• BMI over 35.
• Do not treat patients with the following concurrent diseases:
• Severe peripheral vascular disease.
• Diabetic mellitus with complications.
• Neuropathy or neuropathic disease.
• Active infection or dormant bacteria.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (2)

Orhopaedic Surgery Service, Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

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

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (16)

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• Li Y, Lindeque B. Percutaneous Osseointegrated Prostheses for Transfemoral Amputations. Orthopedics. 2018 Mar 1;41(2):75-80. doi: 10.3928/01477447-20180227-03.

  PMID: 29566253 RESULT

• Zaid MB, O'Donnell RJ, Potter BK, Forsberg JA. Orthopaedic Osseointegration: State of the Art. J Am Acad Orthop Surg. 2019 Nov 15;27(22):e977-e985. doi: 10.5435/JAAOS-D-19-00016.

  PMID: 31181031 RESULT

• Hagberg K. Bone-anchored prostheses in patients with traumatic bilateral transfemoral amputations: rehabilitation description and outcome in 12 cases treated with the OPRA implant system. Disabil Rehabil Assist Technol. 2019 May;14(4):346-353. doi: 10.1080/17483107.2018.1449016. Epub 2018 Mar 14.

  PMID: 29534624 RESULT

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  PMID: 24395320 RESULT

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• Harness N, Pinzur MS. Health related quality of life in patients with dysvascular transtibial amputation. Clin Orthop Relat Res. 2001 Feb;(383):204-7. doi: 10.1097/00003086-200102000-00023.

  PMID: 11210955 RESULT

• Leijendekkers RA, van Hinte G, Frolke JP, van de Meent H, Atsma F, Nijhuis-van der Sanden MW, Hoogeboom TJ. Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study. Clin Rehabil. 2019 Mar;33(3):450-464. doi: 10.1177/0269215518815215. Epub 2018 Dec 12.

  PMID: 30537856 RESULT

• Atallah R, Li JJ, Lu W, Leijendekkers R, Frolke JP, Al Muderis M. Osseointegrated Transtibial Implants in Patients with Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients with 1-Year Follow-up. J Bone Joint Surg Am. 2017 Sep 20;99(18):1516-1523. doi: 10.2106/JBJS.16.01295.

  PMID: 28926380 RESULT

• Akhtar MA, Hoellwarth JS, Al-Jawazneh S, Lu W, Roberts C, Al Muderis M. Transtibial Osseointegration for Patients with Peripheral Vascular Disease: A Case Series of 6 Patients with Minimum 3-Year Follow-up. JB JS Open Access. 2021 Jun 23;6(2):e20.00113. doi: 10.2106/JBJS.OA.20.00113. eCollection 2021 Apr-Jun.

  PMID: 34235362 RESULT

• Hagberg K, Branemark R, Hagg O. Questionnaire for Persons with a Transfemoral Amputation (Q-TFA): initial validity and reliability of a new outcome measure. J Rehabil Res Dev. 2004 Sep;41(5):695-706.

  PMID: 15558399 RESULT

• McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA. 2014 Oct 1;312(13):1342-3. doi: 10.1001/jama.2014.13128. No abstract available.

  PMID: 25268441 RESULT

• Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther. 2012 Aug;20(3):160-6. doi: 10.1179/2042618612Y.0000000001.

  PMID: 23904756 RESULT

• Hung M, Saltzman CL, Kendall R, Bounsanga J, Voss MW, Lawrence B, Spiker R, Brodke D. What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions? Clin Orthop Relat Res. 2018 Oct;476(10):2027-2036. doi: 10.1097/CORR.0000000000000419.

  PMID: 30179950 RESULT

Study Officials

• Christopher H Renninger, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma L Stewart

CONTACT

202-549-3229; emma.l.stewart4.ctr@health.mil

Qingfeng Liu

CONTACT

240-645-3068; Qingfeng.liu.ctr@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-02

Locations

US (2)