Musculoskeletal Diseases

All Conditions

Neoplasms

Rare Diseases

Bone Diseases

Osteosarcoma

Bone Neoplasms

A porous collar for either distal or proximal femoral replacements

A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements

A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements

surgical intervention to place custom made orthopaedic device

custom made device

Panos Gikas, PhD FRCS

Esther Hanison, BSc

The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA, and autologous stem cell augment. This is a randomised controlled trial.

The current surgical treatment of bone cancer patients and revision limb salvage requires usage of massive endoprosthetic bone implants. The incidence of aseptic loosening is a major cause of prosthesis failure in these patients, exploring ways to reduce such failures would allow extending longevity of massive implants in a relatively young population.

Current published literature stipulates that osteointegration could improve longevity of massive implants. Evidence suggests that usage of osteointegrated hydroxyapatite (HA) coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone prosthesis

Massive Implants the Next Generation

A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA or Porous Collar With HA and Autologous Stem Cells

radiological outcomes to determine integration of implant into bone - bone growth

visual analogue pain score to determine improvement of pain over time, 0 to 10 scale will be used (0 = no pain, higher the number the worse the pain)

Adler Ortho

Iva Hauptmannova

Head of Research & Innovation

Wounds and Injuries

Skin and Connective Tissue Diseases

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Osteoarthritis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Congenital Abnormalities

Fractures, Bone

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.

Comprehensive SRS Replacement

Carina Hafner

Lisa To

Kelly Trask

Michael Biddulph

Michael Mork Petersen, MD

Yin Qi, MD

Hassan Achakri

Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.

The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).

Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.

The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.

Comprehensive Segmental Revision System

Implant survivorship assessed counting the number of implant revisions

The QuickDASH score will be used to measure physical function and symptoms of the upper limb in patients to be treated/treated with the Comprehensive SRS products.

The Constant-Murley score may be used to define the level of pain and the ability to carry out the normal daily activities in patients to be treated/treated with the Comprehensive SRS products. The score consists of objective (ROM, strength) and subjective (pain, functional assessment) variables.

The Liverpool Elbow Score may be used to define elbow condition, function and pain in patients to be treated/treated with the Comprehensive SRS products.The score consists of two components: one patient-rated part and another part that can be measured objectively.

The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.

Safety is assessed according to the number of complications which are collected via adverse event forms

Zimmer Biomet

Symptoms and General Pathology

Nervous System Diseases

Syndrome

Rupture

Necrosis

Shoulder Dislocation

Contracture

Wrist Fractures

Trigger Finger Disorder

Lacerations

Dupuytren Contracture

Joint Dislocations

Elbow Fractures

Rotator Cuff Injuries

Shoulder Fractures

Shoulder Injuries

Tendon Injuries

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Tendon Entrapment

Tendinopathy

Any form of joint replacement of the glenohumeral joint including prosthetic and excision.

Shoulder arthroplasty

Any form of joint replacement of the elbow joint including prosthetic and excision.

Elbow arthroplasty

Any form of joint replacement of joints of the hand and wrist including prosthetic and excision.

Hand and wrist arthroplasty

Open or endoscopic release of peripheral nerve entrapment - subdivided by anatomical site of compression. Specific subgroups will include carpal tunnel and cubital tunnel release.

Nerve decompression

Open or arthroscopic repair or reconstruction of tendons of the shoulder, hand and upper limb in general.

Tendon repair

Any procedure designed to increase stability of a joint, including soft tissue and bony blocking procedures.

Joint stabilisation

Any procedure performed for treatment of Dupuytren's contracture.

Excision/division/release of palmar fascia

Any internal or external fixation of upper limb fractures - analysed by anatomical site.

Surgical fixation of fractures

Any removal or release of soft tissue for treatment of stiffness, functional impairment or pain. Specific subgroups will include trigger finger release, subacromial surgery and surgery for frozen shoulder.

Soft tissue release/debridement/excision

Intra-articular injection

Dominic Furniss, DPhil

Surgery is a common treatment type for damaged joints, tendons and nerves in the upper limb where conservative measures are inappropriate or have failed. These conditions are common and result in significant levels of pain and functional disability. The investigators are conducting a broad ranging study of variation in the provision of surgical treatment and factors affecting outcomes after surgical treatment of upper limb conditions. This will be a population-based study of all patients undergoing surgical treatment funded by the National Health Service (NHS) of England over a nineteen-year period. This study will help to understand the factors associated with a poor outcome following surgery, which can be shared with patients considering treatment options. The investigators will also document current and future health service burden associated with commonly performed surgical procedures including complications and repeat operations.

The investigators will conduct time series analyses, geospatial mapping and risk-factor association studies for both access to and outcomes of surgical treatments of the upper limbs. A large cohort of pseudonymised records will be extracted from the NHS Hospital Episode Statistics Admitted Patient Care database. Suitable patients will be identified based on a match to a specified list of International Classification of Diseases (ICD-10) and Office for Population Censuses and Surveys (OPCS-4) codes. Dates and cause of death will be linked from the Office for National Statistics (ONS) by NHS Digital.

Separate analyses will be conducted for different intervention types with detailed outcomes reporting for high volume procedures. Adults will be defined as those aged 18 years or older at the time of surgery. Children will be defined as those aged less than 18 years at surgery and only included in a limited number of analyses where relevant (e.g. trigger digit).

Key analyses:

1. Baseline demographics by procedure type
2. Procedure volume incidence trends

   * Time series analysis
   * Adjusted to standard population distributions
   * Geographical mapping including adjustment for sociodemographic indices including indices of deprivation
3. Revision, reoperation and mortality rates:

   * Estimation by Kaplan Meier and actuarial life table methods
   * Life time risk calculated by the cumulative probability method
   * Cox regression adjusted for comorbidities and demographic, social and geographic factors
4. Complications, length of stay, costs:

   * Logistic and linear regression models for binary and continuous outcomes respectively
   * Adjusted for comorbidities and demographic, social and geographic factors

Where appropriate, the impact of replacing missing data will be explored with use of multiple imputation. All suitable patients will be entered into analyses to maximise statistical efficiency.

Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data

The Role of Patient Factors, Surgical Factors and Hospital Factors Upon Patient Outcomes and NHS Costs in the Treatment of Upper Limb Musculoskeletal Conditions: Spatial and Iongitudinal Analysis of Routine Data

Estimated at annual increments and standardised lifetime risk

Crude and adjusted for population by age/sex

Mapped according to residence and NHS organisation boundaries

Death and infection for all. Specific adverse events dependent on procedure, e.g. periprosthetic fracture after arthroplasty surgery

Number of days - defined by time elapsed between surgery and the end of NHS spell.

Number of patients readmitted to acute NHS trust

Calculated from Healthcare Resource Group codes for index episode and related episodes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Massive Implants the Next Generation	NCT03905174	Bone Cancer Bone Diseases	custom made dev...	18 Years -	Royal National Orthopaedic Hospital NHS Trust
Comprehensive Segmental Revision System	NCT03270982	Degenerative Di... Oncology Revision Surger... Trauma Rheumatoid Arth...	Comprehensive S...	-	Zimmer Biomet
Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data	NCT03573765	Osteoarthritis Dislocations Inflammatory Ar... Rotator Cuff Te... Shoulder Disloc... Upper Limb Nerv... Shoulder Arthro... Elbow Arthropat... Wrist Arthropat... Arthropathy Uns... Fracture, Shoul... Fracture Elbow Fracture Wrist ... Dupuytren Contr... Impingement Syn... Trigger Digit Avascular Necro...	Shoulder arthro... Elbow arthropla... Hand and wrist ... Nerve decompres... Tendon repair Joint stabilisa... Excision/divisi... Surgical fixati... Soft tissue rel... Intra-articular...	-	University of Oxford

Spots Global Cancer Trial Database for revision surgery