Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion

NCT05574582 | Recruiting DMC

• 1 other identifier: RCT Scaphoid delayed/nonunion
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed/nonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand/upper extremity, previous failed surgical treatment for scaphoid delayed/nonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity. Patients are stratified for smoking habits, proximal pole involvement, and displacement of \>/\<2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.

Conditions

Scaphoid Fracture; Scaphoid Nonunion

Keywords

Scaphoid; Scaphoid nonunion; Cancellous; Graft; Arthroscopic; Timo to union

Outcome Measures

Primary Outcomes (1)

• Time to Union

  Assessed with CT-scans. Union is proclaimed if at least 50% bone bridging is recorded together with absence of pain in the clinical examination

  6-16 weeks postoperative in 2 weeks intervals. If unions is not achieved a CT will be made 26 weeks postoperatively. If union is not achieved at that point, the patient will be presented for another treatment modality

Secondary Outcomes (7)

• The Quick Disability of the Arm, Shoulder, and Hand (Q-DASH)

  Preoperatively, 1.5 md, 3md, 6md, 12md, 24md, 60md, and 120 months postoperative

• Union rate

  6-16 weeks postoperative. If unions is not achieved a CT will be made 26 weeks postoperatively

• Correction of deformity

  Before surgery compared to CT-scan with >50% bone bridging.

• Pain (VAS)

  Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative

• Donor site morbidity

  Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative

Other Outcomes (3)

• Patient satisfaction

  Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative

• EQ5D-5L

  Baseline and 2-year follow up scores will be compared

• Complications and secondary surgery

  Preoperatively, 1.5, 3, 6, 12 and 24 months postoperative

Study Arms (2)

Arthroscopic assisted Cancellous chips graft reconstruction

EXPERIMENTAL

The arthroscopic technique is potentially less invasive with minimal donor site morbidity and potentially faster time to union because of minimal trauma to the ligament structures, joint capsule, and the tenuous blood supply. It may also have advantageous osteogenic properties compared to a structural graft. Currently, studies have reported similar union rates, patient reported outcomes score, and functional score compared to open graft technique. Results in patients with gross deformity are debated with some studies favoring conventional open structural graft and other found no difference in outcome between the techniques.

Procedure: Graft reconstruction and internal fixation with compression screw

Open cancellous graft reconstruction

ACTIVE COMPARATOR

Convention open technique with debridement of the nonunion side, insertion of cancellous graft from the iliac crest and osteosynthesis with compression screw is currently commonly applied in scaphoid nonunion.

Procedure: Graft reconstruction and internal fixation with compression screw

Interventions

Graft reconstruction and internal fixation with compression screw PROCEDURE

Patients suffering from scaphoid nonunion are treated surgically by debridement, graft reconstruction and internal fixation with compression screw

Arthroscopic assisted Cancellous chips graft reconstruction; Open cancellous graft reconstruction

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-68 years.
• A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \>1mm or comminution and failed non-operative treatment.
• Scaphoid fracture without healing \>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.
• ASA 1-3.

You may not qualify if:

• Open fractures
• Associated trans-scaphoid perilunate dislocation.
• Associated fracture in the hand/upper extremity.
• Previous failed surgical treatment for scaphoid delayed/non-union.
• Stage 2 SNAC or above.
• Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.
• Patients with gross humpback deformity of HLR \>0.75 and/or DCA \<70⁰.
• Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

University Hospital Herlev/Gentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark

Hellerup, 2900, Denmark

RECRUITING

Related Publications (47)

• Jorgsholm P, Ossowski D, Thomsen N, Bjorkman A. Epidemiology of scaphoid fractures and non-unions: A systematic review. Handchir Mikrochir Plast Chir. 2020 Sep;52(5):374-381. doi: 10.1055/a-1250-8190. Epub 2020 Sep 29.

  PMID: 32992390 BACKGROUND

• Cooney WP 3rd, Dobyns JH, Linscheid RL. Nonunion of the scaphoid: analysis of the results from bone grafting. J Hand Surg Am. 1980 Jul;5(4):343-54. doi: 10.1016/s0363-5023(80)80173-0.

  PMID: 6999072 BACKGROUND

• Linscheid RL, Dobyns JH, Beabout JW, Bryan RS. Traumatic instability of the wrist: diagnosis, classification, and pathomechanics. J Bone Joint Surg Am. 2002 Jan;84(1):142. doi: 10.2106/00004623-200201000-00020. No abstract available.

  PMID: 11792792 BACKGROUND

• Grewal R, Suh N, MacDermid JC. The Missed Scaphoid Fracture-Outcomes of Delayed Cast Treatment. J Wrist Surg. 2015 Nov;4(4):278-83. doi: 10.1055/s-0035-1564983.

  PMID: 26649260 BACKGROUND

• Little CP, Burston BJ, Hopkinson-Woolley J, Burge P. Failure of surgery for scaphoid non-union is associated with smoking. J Hand Surg Br. 2006 Jun;31(3):252-5. doi: 10.1016/j.jhsb.2005.12.010. Epub 2006 Feb 20.

  PMID: 16488521 BACKGROUND

• Schuind F, Moungondo F, El Kazzi W. Prognostic factors in the treatment of carpal scaphoid non-unions. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):3-9. doi: 10.1007/s00590-016-1886-4. Epub 2016 Nov 28.

  PMID: 27896458 BACKGROUND

• Grewal R, Suh N, Macdermid JC. Use of computed tomography to predict union and time to union in acute scaphoid fractures treated nonoperatively. J Hand Surg Am. 2013 May;38(5):872-7. doi: 10.1016/j.jhsa.2013.01.032. Epub 2013 Mar 23.

  PMID: 23531510 BACKGROUND

• Ramamurthy C, Cutler L, Nuttall D, Simison AJ, Trail IA, Stanley JK. The factors affecting outcome after non-vascular bone grafting and internal fixation for nonunion of the scaphoid. J Bone Joint Surg Br. 2007 May;89(5):627-32. doi: 10.1302/0301-620X.89B5.18183.

  PMID: 17540748 BACKGROUND

• Buijze GA, Wijffels MM, Guitton TG, Grewal R, van Dijk CN, Ring D; Science of Variation Group. Interobserver reliability of computed tomography to diagnose scaphoid waist fracture union. J Hand Surg Am. 2012 Feb;37(2):250-4. doi: 10.1016/j.jhsa.2011.10.051.

  PMID: 22281168 BACKGROUND

• Guldbrandsen CW, Radev DI, Gvozdenovic R. Normal ranges for measurements of the scaphoid bone from sagittal computed tomography images. J Hand Surg Eur Vol. 2021 Jul;46(6):594-599. doi: 10.1177/1753193420987522. Epub 2021 Jan 17.

  PMID: 33459143 BACKGROUND

• Bain GI, Bennett JD, MacDermid JC, Slethaug GP, Richards RS, Roth JH. Measurement of the scaphoid humpback deformity using longitudinal computed tomography: intra- and interobserver variability using various measurement techniques. J Hand Surg Am. 1998 Jan;23(1):76-81. doi: 10.1016/S0363-5023(98)80093-2.

  PMID: 9523959 BACKGROUND

• Merrell GA, Wolfe SW, Slade JF 3rd. Treatment of scaphoid nonunions: quantitative meta-analysis of the literature. J Hand Surg Am. 2002 Jul;27(4):685-91. doi: 10.1053/jhsu.2002.34372.

  PMID: 12132096 BACKGROUND

• Sayegh ET, Strauch RJ. Graft choice in the management of unstable scaphoid nonunion: a systematic review. J Hand Surg Am. 2014 Aug;39(8):1500-6.e7. doi: 10.1016/j.jhsa.2014.05.009. Epub 2014 Jul 3.

  PMID: 24997785 BACKGROUND

• Huang YC, Liu Y, Chen TH. Long-term results of scaphoid nonunion treated by intercalated bone grafting and Herbert's screw fixation--a study of 49 patients for at least five years. Int Orthop. 2009 Oct;33(5):1295-300. doi: 10.1007/s00264-008-0663-3. Epub 2008 Oct 28.

  PMID: 18956188 BACKGROUND

• Goyal T, Sankineani SR, Tripathy SK. Local distal radius bone graft versus iliac crest bone graft for scaphoid nonunion: a comparative study. Musculoskelet Surg. 2013 Aug;97(2):109-14. doi: 10.1007/s12306-012-0219-y. Epub 2012 Sep 12.

  PMID: 22968662 BACKGROUND

• Oh WT, Kang HJ, Chun YM, Koh IH, Lee YJ, Choi YR. Retrospective Comparative Outcomes Analysis of Arthroscopic Versus Open Bone Graft and Fixation for Unstable Scaphoid Nonunions. Arthroscopy. 2018 Oct;34(10):2810-2818. doi: 10.1016/j.arthro.2018.04.024. Epub 2018 Aug 30.

  PMID: 30173911 BACKGROUND

• Chu PJ, Shih JT. Arthroscopically assisted use of injectable bone graft substitutes for management of scaphoid nonunions. Arthroscopy. 2011 Jan;27(1):31-7. doi: 10.1016/j.arthro.2010.05.015. Epub 2010 Oct 8.

  PMID: 20934844 BACKGROUND

• Lee YK, Choi KW, Woo SH, Ho PC, Lee M. The clinical result of arthroscopic bone grafting and percutaneous K-wires fixation for management of scaphoid nonunions. Medicine (Baltimore). 2018 Mar;97(13):e9987. doi: 10.1097/MD.0000000000009987.

  PMID: 29595703 BACKGROUND

• Slade JF 3rd, Geissler WB, Gutow AP, Merrell GA. Percutaneous internal fixation of selected scaphoid nonunions with an arthroscopically assisted dorsal approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:20-32. doi: 10.2106/00004623-200300004-00003.

  PMID: 14652390 BACKGROUND

• Kim JP, Seo JB, Yoo JY, Lee JY. Arthroscopic management of chronic unstable scaphoid nonunions: effects on restoration of carpal alignment and recovery of wrist function. Arthroscopy. 2015 Mar;31(3):460-9. doi: 10.1016/j.arthro.2014.08.035. Epub 2014 Nov 4.

  PMID: 25442643 BACKGROUND

• Kang HJ, Chun YM, Koh IH, Park JH, Choi YR. Is Arthroscopic Bone Graft and Fixation for Scaphoid Nonunions Effective? Clin Orthop Relat Res. 2016 Jan;474(1):204-12. doi: 10.1007/s11999-015-4495-3. Epub 2015 Aug 7.

  PMID: 26250139 BACKGROUND

• Cognet JM, Louis P, Martinache X, Schernberg F. Arthroscopic grafting of scaphoid nonunion - surgical technique and preliminary findings from 23 cases. Hand Surg Rehabil. 2017 Feb;36(1):17-23. doi: 10.1016/j.hansur.2016.11.002. Epub 2016 Dec 29.

  PMID: 28137436 BACKGROUND

• Hsiung W, Huang HK, Wang JP, Chang MC, Huang YC. Arthroscopic realignment and osteosynthesis of unstable scaphoid nonunion with cancellous bone graft from the ipsilateral radius. Int Orthop. 2021 Jan;45(1):191-197. doi: 10.1007/s00264-020-04840-2. Epub 2020 Oct 13.

  PMID: 33048201 BACKGROUND

• Waitayawinyu T, Lertcheewanan W, Boonyasirikool C, Niempoog S. Arthroscopic Treatment of Scaphoid Nonunion With Olecranon Bone Graft and Screw Fixation Leads to Union and Improved Outcomes. Arthroscopy. 2022 Mar;38(3):761-772. doi: 10.1016/j.arthro.2021.09.018. Epub 2021 Sep 25.

  PMID: 34571185 BACKGROUND

• Hackney LA, Dodds SD. Assessment of scaphoid fracture healing. Curr Rev Musculoskelet Med. 2011 Mar 8;4(1):16-22. doi: 10.1007/s12178-011-9072-0.

  PMID: 21475561 BACKGROUND

• Hannemann PF, Brouwers L, van der Zee D, Stadler A, Gottgens KW, Weijers R, Poeze M, Brink PR. Multiplanar reconstruction computed tomography for diagnosis of scaphoid waist fracture union: a prospective cohort analysis of accuracy and precision. Skeletal Radiol. 2013 Oct;42(10):1377-82. doi: 10.1007/s00256-013-1658-8. Epub 2013 Jun 6.

  PMID: 23740357 BACKGROUND

• Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

  PMID: 8773720 BACKGROUND

• Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44.

  PMID: 16709254 BACKGROUND

• Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.

  PMID: 24175606 BACKGROUND

• Roh YH, Noh JH, Lee BK, Baek JR, Oh JH, Gong HS, Baek GH. Reliability and validity of carpal alignment measurements in evaluating deformities of scaphoid fractures. Arch Orthop Trauma Surg. 2014 Jun;134(6):887-93. doi: 10.1007/s00402-014-1998-4. Epub 2014 Apr 23.

  PMID: 24756533 BACKGROUND

• Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.

  PMID: 18796752 BACKGROUND

• Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.

  PMID: 6715829 BACKGROUND

• Kvien TK, Heiberg T, Hagen KB. Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean? Ann Rheum Dis. 2007 Nov;66 Suppl 3(Suppl 3):iii40-1. doi: 10.1136/ard.2007.079798.

  PMID: 17934093 BACKGROUND

• Pinder RM, Brkljac M, Rix L, Muir L, Brewster M. Treatment of Scaphoid Nonunion: A Systematic Review of the Existing Evidence. J Hand Surg Am. 2015 Sep;40(9):1797-1805.e3. doi: 10.1016/j.jhsa.2015.05.003. Epub 2015 Jun 24.

  PMID: 26116095 BACKGROUND

• Hegazy G, Massoud AH, Seddik M, Abd-Elghany T, Abdelaal M, Saqr Y, Abdelaziz M, Zayed E, Hassan M. Structural Versus Nonstructural Bone Grafting for the Treatment of Unstable Scaphoid Waist Nonunion Without Avascular Necrosis: A Randomized Clinical Trial. J Hand Surg Am. 2021 Jun;46(6):462-470. doi: 10.1016/j.jhsa.2021.01.027. Epub 2021 Apr 1.

  PMID: 33814250 BACKGROUND

• Kim JK, Yoon JO, Baek H. Corticocancellous bone graft vs cancellous bone graft for the management of unstable scaphoid nonunion. Orthop Traumatol Surg Res. 2018 Feb;104(1):115-120. doi: 10.1016/j.otsr.2017.11.011. Epub 2017 Dec 16.

  PMID: 29258960 BACKGROUND

• Cohen MS, Jupiter JB, Fallahi K, Shukla SK. Scaphoid waist nonunion with humpback deformity treated without structural bone graft. J Hand Surg Am. 2013 Apr;38(4):701-5. doi: 10.1016/j.jhsa.2012.12.030. Epub 2013 Feb 13.

  PMID: 23415167 BACKGROUND

• Yang H, Bullock WA, Myhal A, DeShield P, Duffy D, Main RP. Cancellous Bone May Have a Greater Adaptive Strain Threshold Than Cortical Bone. JBMR Plus. 2021 Mar 30;5(5):e10489. doi: 10.1002/jbm4.10489. eCollection 2021 May.

  PMID: 33977205 BACKGROUND

• Singh HP, Forward D, Davis TR, Dawson JS, Oni JA, Downing ND. Partial union of acute scaphoid fractures. J Hand Surg Br. 2005 Oct;30(5):440-5. doi: 10.1016/j.jhsb.2005.05.007.

  PMID: 16006021 BACKGROUND

• Lozano-Calderon S, Blazar P, Zurakowski D, Lee SG, Ring D. Diagnosis of scaphoid fracture displacement with radiography and computed tomography. J Bone Joint Surg Am. 2006 Dec;88(12):2695-703. doi: 10.2106/JBJS.E.01211.

  PMID: 17142420 BACKGROUND

• Dias JJ, Taylor M, Thompson J, Brenkel IJ, Gregg PJ. Radiographic signs of union of scaphoid fractures. An analysis of inter-observer agreement and reproducibility. J Bone Joint Surg Br. 1988 Mar;70(2):299-301. doi: 10.1302/0301-620X.70B2.3346310.

  PMID: 3346310 BACKGROUND

• Hannemann PFW, Brouwers L, Dullaert K, van der Linden ES, Poeze M, Brink PRG. Determining scaphoid waist fracture union by conventional radiographic examination: an analysis of reliability and validity. Arch Orthop Trauma Surg. 2015 Feb;135(2):291-296. doi: 10.1007/s00402-014-2147-9. Epub 2015 Jan 3.

  PMID: 25555379 BACKGROUND

• Farracho LC, Moutinot B, Neroladaki A, Hamard M, Gorican K, Poletti PA, Beaulieu JY, Bouvet C, Boudabbous S. Determining diagnosis of scaphoid healing: Comparison of cone beam CT and X-ray after six weeks of immobilization. Eur J Radiol Open. 2020 Sep 2;7:100251. doi: 10.1016/j.ejro.2020.100251. eCollection 2020.

  PMID: 32944592 BACKGROUND

• Biswas D, Bible JE, Bohan M, Simpson AK, Whang PG, Grauer JN. Radiation exposure from musculoskeletal computerized tomographic scans. J Bone Joint Surg Am. 2009 Aug;91(8):1882-9. doi: 10.2106/JBJS.H.01199.

  PMID: 19651945 BACKGROUND

• Zhou Q. [Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals]. Zhonghua Gan Zang Bing Za Zhi. 2014 Oct;22(10):781-91. No abstract available. Chinese.

  PMID: 25558501 BACKGROUND

• World Medical Association Inc. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc. 2009 Jun;107(6):403-5. No abstract available.

  PMID: 19886379 BACKGROUND

• Kjaer M, Rasmussen JV, Gvozdenovic R. Arthroscopic versus open cancellous bone grafting for scaphoid delayed/nonunion in adults (SCOPE-OUT): study protocol for a randomized clinical trial. Trials. 2023 Apr 14;24(1):273. doi: 10.1186/s13063-023-07281-5.

  PMID: 37060040 DERIVED

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Robert Gvozdenoviz, MD

  Orthopedic department, Copenhagen university hospital Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Kjaer, MD

CONTACT

+45 38672111; morten.kjaer.02@regionh.dk

Camilla Stokkebro, Secretary

CONTACT

+45 38673280; camilla.stokkebro@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: observer-blinded RCT, union is assessed by a blinded musculoskeletal radiologist. QDASH is a patient-reported survey, without the involvement of surgeons or research staff. Other secondary outcomes will be measured by an independent observer. The study will not be blinded to the operating theatre staff, surgeons, physiotherapists, or patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD student

Model Details: 1:1 observer-blinded randomized controlled, superiority trial. The main objective is to compare open C graft with arthroscopic assisted C chips graft reconstruction for scaphoid fractures with delayed/non-union. Based on the sample size calculation, a total of 88 patients with scaphoid delayed/non-union are randomized to either: 1. Group A - Arthroscopic assisted C chips graft reconstruction (intervention group), n=44 2. Group O - Open C graft reconstruction (control group), n=44 The randomization is done in the outpatient clinic and the patients will be informed about the operative treatment. The randomization application, Research Electronic Data Capture (REDCap), will allocate patients in a 1:1 ratio, stratified for proximal pole fracture (yes /no), dislocation (\>/\< 2mm), and smoking (yes/ no). A statistician will generate a randomization sequence for REDCap.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 10, 2022
• Study Start: February 15, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available when the study results are published. The data will be available for 10 years after finishing of recruitment, as accepted by the Danish Data Protection Agency (Pactius).
• Access Criteria: On request with relevant argumentation for intended use, and acceptance by the data protection agency.

Locations

DK (1)