| Literature DB >> 35668394 |
Cedric Lester Magaway1, Gerard Malanga2,3.
Abstract
There has been increasing evidence and growing popularity of orthobiologic treatments, such as platelet-rich plasma, bone marrow aspirate concentrate, and microfragmented adipose tissue. However, real-world data, including patient-reported pain and function outcomes, remains sparse for these procedures. Thus, collecting patient-reported outcome measures is important to evaluate the safety and efficacy of these treatments and hopefully improve patient care. Patient reported outcome measures can systematically be collected through patient registries. This narrative review serves to describe the data collection platforms and registries that obtain patient-reported outcome measures on orthobiologic procedures and provide a discussion on the benefits and limitations of registries. An internet search of the list of orthopedic registries available was conducted, and registries that collect patient-reported outcome measures for orthobiologic procedures were identified. Additional information regarding these various registries was collected by directly contacting these vendors. Publications from these registries, including case series, observational studies, and annual reports, were also reviewed. Providing this review will inform clinicians of a digital tool that can increase the efficiency of collecting outcome measures for orthobiologics and aid physicians in choosing a data collection platform.Entities:
Keywords: Musculoskeletal Conditions; Orthobiologics; Outcomes Assessment/Measurement
Mesh:
Year: 2022 PMID: 35668394 PMCID: PMC9171990 DOI: 10.1186/s12891-022-05416-4
Source DB: PubMed Journal: BMC Musculoskelet Disord ISSN: 1471-2474 Impact factor: 2.562
Fig. 1Summary of Review
Summary of Orthobiologics and PROMs
| Registry/Data Collection Platform | Orthobiologic Procedures | Patient Reported Outcome Measures Used | HIPAA Compliant | |
|---|---|---|---|---|
| Oberd – Regenerative Orthobiologics Registry (ROR) | A2M Amnion Matrix Allograft Fibrin Matrix Cord Allograft Plasma Concentrate Platelet Lysate PPP PRP Stem Cells | Global Health Measures | Adverse events EQ-50 NASS Satisfaction Index NPRS PROMIS (PROMIS 10 or CAT) SANE VR-12 | Yes |
| Upper Extremity | ASES Standardized Shoulder Assessment DASH quickDASH OSS WOSI | |||
| Hip | HOOS, HOOS, Jr. | |||
| Knee | KOOS, KOOS Jr. MARS PEDI-IKDC | |||
| Foot and Ankle | FAAM FADI | |||
| Spine | ODI NDI | |||
| Oberd – AO Global Data Registry | Allografts Scaffolds | Global Health Measures | PROMIS Short Form v1.0: Pain Interference 6b PROMIS Short Form v2.0: Physical Function 10a PROMIS Global Health SANE Visual Analog Scale | Yes |
| Upper Extremity | ASES Shoulder Assessment QuickDASH PROMIS Short Form V2.0: Upper Extremity 7a | |||
| Hip | HOOS Jr. | |||
| Knee | KOOS Jr. | |||
| Foot and Ankle | FAAM | |||
| Spine | NDI ODI | |||
| Code Technology | Allografts BMAC MFAT PRP Scaffolds | Global Health Measures | EQ-5D PROMIS Global 10 SF-36 VR-12 | Yes |
| Upper Extremity | ASES Shoulder Score DASH OSS PENN Shoulder Score SPADI UCLA Shoulder Score WOSI | |||
| Hip | AAOS Hip & Knee Score Harris Hip Score Hip Outcome Score HOOS, HOOS Jr. Oxford Hip Score | |||
| Knee | IKDC KOOS, KOOS Jr. Knee Society Score Lysholm Knee Scoring System MARS Oxford Knee Score WOMAC | |||
| Foot and Ankle | AOFAS FAAM | |||
| Spine | NDI ODI | |||
| DataBiologics | A2M BMAC MFAT Plasma Lysate PPP PRP Prolotherapy Shock Wave Therapy | Global Health Measures | Adverse Events NPRS PHQ-4 | Yes |
| Upper Extremity | QuickDASH | |||
| Hip | HOOS Jr. | |||
| Knee | KOOS Jr. | |||
| Foot and Ankle | FAAM VISA-A | |||
| Spine | NDI ODI | |||
| InCytes | Allografts BMAC Exosomes MFAT PRP Scaffolds Wharton’s Jelly | Global Health Measures | EQ-5D NPRS SF-12 SF-36 PROMIS VAS | Yes |
| Upper Extremity | DASH QuickDASH PRTEE WORC, Short WORC WOSI | |||
| Hip | HOOS, HOOS Jr. iHOT-12 WOMAC | |||
| Knee | IKDC KOOS, KOOS Jr. Lysholm Knee Scoring Scale MOCART TAS VISA-P WOMAC | |||
| Foot and Ankle | FAAM FADI FFI MFPDI VISA-A | |||
| Spine | NDI ODI, ODI - Modified | |||
| OutcomeMD | Allografts BMAC MFAT PRP Scaffolds | Global Health Measures | PROMIS | Yes |
| Upper Extremity | ASES Shoulder Score IOF Wrist Fracture QuickDASH | |||
| Hip | HOOS Jr. mHHS | |||
| Knee | KOOS Jr. | |||
| Foot and Ankle | ATRS FAAm FFI-R | |||
| Spine | NDI ODI | |||
| Amplitude Clinical Outcomes – International Cartilage Regeneration and Joint Preservation Society (ICRS) | Allografts Autologous anti-inflammatory injections BMAC MFAT PRP Scaffolds Stem Cell Amniotic-Based Injections | Global Health Measures | EQ-5D | Yes |
| Knee | KOOS Kujala Anterior Knee Pain Scale | |||
| Arthrex - Surgical Outcomes System | Allografts BMAC MFAT PRP Scaffolds | Global Health Measures | PROMIS-10 SANE VAS VR-12 | Yes |
| Upper Extremity | ASES-Elbow Score ASES Shoulder Score bMHQ CTS-6 KJOC Shoulder and Elbow Score Oxford Shoulder Score Penn Shoulder Score QuickDASH SST WORC WOOS WOSI | |||
| Hip | iHOT-12 mHHS NAHS Oxford Hip Score VHS | |||
| Knee | IKDC Knee Society Score Lysholm Knee Scoring System Knee Society Score KOOS, KOOS Jr. MARS MOCART Oxford Knee Score TAS | |||
| Foot and Ankle | AOFAS FAAM FFI-R MOCART | |||
| Spine | NDI ODI | |||
| Ortech | Allografts BMAC MFAT PRP Scaffolds | Global Health Measures | EQ-50 PROMIS 10 or CAT SANE VR-12 | Yes |
| Upper Extremity | ASES Shoulder Score DASH QuickDASH Oxford Shoulder Score WOSI | |||
| Hip | HOOS, HOOS Jr. | |||
| Knee | Pedi-IKDC KOOS, KOOS Jr. MARS | |||
| Foot and Ankle | FAAM FADI | |||
| Spine | NDI ODI | |||
| PatientIQ | BMAC PRP | Global Health Measures | EQ-50 PROMIS (PROMIS 10 or CAT) SANE VR-12 | |
| Upper Extremity | ASES Standardized Shoulder Assessment DASH quickDASH OSS WOSI | |||
| Hip | HOOS, HOOS, Jr. | |||
| Knee | KOOS, KOOS Jr. MARS PEDI-IKDC | |||
| Foot and Ankle | FAAM FADI | |||
| DADOS | N/A | N/A | N/A | Yes |
| EUROSPINE – Spine Tango | Bone grafts Bone Morphogenetic Proteins Scaffolds | Global Health Measures | EQ-3D SF-36 | Yes – European Equivalent |
| Spine | COMI-Back NDI ODI SRS-30 | |||
Summary of Registry Features and Costs
| Registry/Data Collection Platform | Reminder Types | Compatible Devices | Costs | Partnerships & Sponsorships |
|---|---|---|---|---|
| Oberd – Regenerative Orthobiologics Registry (ROR) | Text Phone | Mobile Devices Tablets Personal Computers | $300 per provider per month | ROR |
| Oberd – AO Global Data Registry | Text | Mobile Devices Tablets Personal Computers | N/A | AAOS, AJRR, ASES, AO Foundation |
| Code Technology | Text Phone | Mobile Devices Tablets Personal Computers | Per provider and per procedure pricing models available | Over 27 organizations, including AAOS, AJRR, NASS, CJRR, MARCQI, Moon ACL Registry |
| DataBiologics | Text | Mobile Devices Tablets Personal Computers | $1500 per year | TOBI |
| InCytes | Text | Mobile Devices Tablets Personal Computers | Annual model: $3000 per year for up to 5 users and 100 cases overall; $5–10 per additional case Monthly model: $35 per month per account | |
| OutcomeMD | Text Phone | Mobile Devices Tablets Personal Computers | $95 per provider per month | ICHOM |
| Amplitude Clinical Outcomes – International Cartilage Regeneration and Joint Preservation Society (ICRS) | Text | Mobile Devices Tablets Personal Computers | $850 per provider per year | British Society for Surgery of the Hand, British Spine Registry, National Ligament Registry, ICRS |
| Arthrex - Surgical Outcomes System | Mobile Devices Tablets Personal Computers | $200 per provider per month Free with membership to American Orthopedic Society for Sports Medicine, Irish Shoulder and Elbow Society, American Shoulder and Elbow Surgeons, Arthroscopy Association of North America, and Eastern Orthopedic Association | AANA, ASES, AOSSM, EOA | |
| Ortech | Text | Mobile Devices Tablets Personal Computers | $6000 per provider for the first year $3000 per provider per year after | CJRR, AJRR, MARCQI, NASS, Alberta Arthroplasty Database, Nova Scotia Health Authority Joint Registry |
| PatientIQ | Text | Mobile Devices Tablets Personal Computers | N/A | AAOS Registry Program |
| DADOS | Mobile Devices Tablets Personal Computers | N/A | ||
| EUROSPINE – Spine Tango | Text | Mobile Devices Tablets Personal Computers | Free to any EUROSPINE member | EUROSPINE |