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This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor three months after implantation/surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgery | Procedure | The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants With Reliable Anchorage for a Sound Processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor. | 3 months after implant surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants With Reliable Anchorage for a Sound Processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Powell, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| Univerisity Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39186326 | Derived | Teunissen EM, Aukema TW, Banga R, Eeg-Olofsson M, Hol MKS, Hougaard DD, Tysome JR, Johansson ML, Svensson S, Powell HRF. Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study. Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm | In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm | In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Implants With Reliable Anchorage for a Sound Processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor. | Posted | Count of Units | Implants | 3 months after implant surgery | Implants | Implants |
|
12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm | In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (abdomen, back) | Nervous system disorders | Non-systematic Assessment | Hospitalisation because of abdominal- and backpain (pre-existing abdominal aneurysm) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Non-systematic Assessment | Pain around implant/abutment area. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Oticon Medical | +46 31 748 6100 | studyinfo@oticonmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2020 | Mar 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Glasgow Benefit Inventory (GBI) | Other | A quality of life-questionnaire is to be completed by the subjects at one occasion. |
|
| Additional follow-up visits after surgery | Other | There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics). |
|
| 12 months after implant surgery |
| Implant Survival | Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No] | 12 months after implant surgery |
| Implant Stability | Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No] | 12 months after implant surgery |
| Holgers Score Distribution | Distribution of Holgers score ratings assigned by investigator across all study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. The results are presented based on Holgers score distribution across all study visits, as well as separate for each study visit and for unplanned visits. | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits |
| Max Holgers Score | Max Holgers score rating per patient across study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. | 12 months after implant surgery |
| Mild/Adverse Skin Reaction | Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. | 12 months after implant surgery |
| IPS (Inflammation, Pain, Skin Height) Scores | Distribution of IPS scores assigned by investigator across all study visits. The IPS scale is used to assess soft tissue status including inflammation (I), pain (P), and skin height (S) for a skin-penetrating implant, with scores ranging from 0 to 4 for the I-scale, and from 0 to 2 for the P- and S-scales. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score reflects a more severe complication. The results are presented based on IPS score distribution across all study visits, as well as separate for each study visit and unplanned visits. | 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits |
| Wound Healing | Investigator assessment of wound being completely healed by means of a Yes/No question. The results are presented for each study visit and for unplanned visits. | 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits |
| Skin Overgrowth | Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. The results are presented for each study visit and for unplanned visits. | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits |
| Post-operative Events Around Abutment | Assessment of post-operative events by investigator into five different categories: None, Bleeding and/or hematoma, Hair in-growth, Skin dehiscence around abutment, and Other. The results are presented based on post-operative event distribution across all study visits, as well as separate for each study visit and unplanned visits. | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits |
| Patient-perceived Presence of Pain Around Abutment | Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject. | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits |
| Patient-perceived Presence of Numbness Around Abutment | Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient. | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits |
| Duration of Surgery | Length of surgery measured in minutes. | 3 months after implant surgery |
| Sound Processor Usage | Average sound processor usage time. | 12 months after implant surgery |
| Subjective Benefit After Surgery | The Glasgow Benefit Inventory (GBI) is a validated, 18-item patient-reported questionnaire that assesses changes in health-related quality-of-life following otorhinolaryngological (ENT) interventions. The questionnaire evaluates the perceived benefit after a procedure and generates a Total Score and three subscale scores: General (12 items), Social Support (3 items), and Physical Health (3 items). Each score ranges from -100 to +100, where positive values indicate improvement, negative values indicate deterioration, and zero reflects no change. The Total Score is calculated as the mean of all item scores (not a sum of subscale scores), while each subscale score is calculated as the mean of the items belonging to that subscale. | 3 months after surgery |
| Groningen |
| Netherlands |
| Radboud University Medical Center | Nijmegen | 6525EX | Netherlands |
| Sahlgrenska University Hospital | Gothenburg | 413 46 | Sweden |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2WB | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| Implants |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 | Participants |
|
| Smoking | Count of Participants | Participants | Participants |
|
| Hearing loss indication | Duplicate hearing loss indications were reported for four participantients (e.g. for different ears). | Count of Participants | Participants | Participants |
|
|
|
| Secondary | Number of Implants With Reliable Anchorage for a Sound Processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor. | Posted | Count of Units | Implants | 12 months after implant surgery | Implants | Implants |
|
|
|
| Secondary | Implant Survival | Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No] | Posted | Count of Units | Implants | 12 months after implant surgery | Implants | Implants |
|
|
|
| Secondary | Implant Stability | Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No] | Posted | Count of Units | Implants | 12 months after implant surgery | Implants | Implants |
|
|
|
| Secondary | Holgers Score Distribution | Distribution of Holgers score ratings assigned by investigator across all study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. The results are presented based on Holgers score distribution across all study visits, as well as separate for each study visit and for unplanned visits. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Holgers scores were reported in a total of 22 unplanned visits. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Max Holgers Score | Max Holgers score rating per patient across study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. | Posted | Count of Units | Implants | 12 months after implant surgery | Implants | Implants |
|
|
|
| Secondary | Mild/Adverse Skin Reaction | Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Holgers scores were reported in a total of 22 unplanned visits. | Posted | Count of Units | Visits | 12 months after implant surgery | Visits | Visits |
|
|
|
| Secondary | IPS (Inflammation, Pain, Skin Height) Scores | Distribution of IPS scores assigned by investigator across all study visits. The IPS scale is used to assess soft tissue status including inflammation (I), pain (P), and skin height (S) for a skin-penetrating implant, with scores ranging from 0 to 4 for the I-scale, and from 0 to 2 for the P- and S-scales. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score reflects a more severe complication. The results are presented based on IPS score distribution across all study visits, as well as separate for each study visit and unplanned visits. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. IPS scores were reported in a total of 22 unplanned visits. For one unplanned visit, only I- and P-scores were reported. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Wound Healing | Investigator assessment of wound being completely healed by means of a Yes/No question. The results are presented for each study visit and for unplanned visits. | Wound healing status was reported in a total of 17 unplanned visits. | Posted | Count of Units | Visits | No | 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Skin Overgrowth | Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. The results are presented for each study visit and for unplanned visits. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of skin overgrowth was reported in a total of 22 unplanned visits. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Post-operative Events Around Abutment | Assessment of post-operative events by investigator into five different categories: None, Bleeding and/or hematoma, Hair in-growth, Skin dehiscence around abutment, and Other. The results are presented based on post-operative event distribution across all study visits, as well as separate for each study visit and unplanned visits. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. For one visit, two post-operative events were reported for the same implant. Post-operative events were reported in a total of 25 unplanned visits. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Patient-perceived Presence of Pain Around Abutment | Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of pain was reported in a total of 23 unplanned visits. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Patient-perceived Presence of Numbness Around Abutment | Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient. | The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of numbness was reported in a total of 23 unplanned visits. | Posted | Count of Units | Visits | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Visits | Visits |
|
|
|
| Secondary | Duration of Surgery | Length of surgery measured in minutes. | Posted | Mean | Standard Deviation | minutes | 3 months after implant surgery | Implants | Implants |
|
|
|
| Secondary | Sound Processor Usage | Average sound processor usage time. | Participants using the sound processor daily at 12 months after surgery | Posted | Mean | Standard Deviation | hours per day | 12 months after implant surgery |
|
|
|
| Secondary | Subjective Benefit After Surgery | The Glasgow Benefit Inventory (GBI) is a validated, 18-item patient-reported questionnaire that assesses changes in health-related quality-of-life following otorhinolaryngological (ENT) interventions. The questionnaire evaluates the perceived benefit after a procedure and generates a Total Score and three subscale scores: General (12 items), Social Support (3 items), and Physical Health (3 items). Each score ranges from -100 to +100, where positive values indicate improvement, negative values indicate deterioration, and zero reflects no change. The Total Score is calculated as the mean of all item scores (not a sum of subscale scores), while each subscale score is calculated as the mean of the items belonging to that subscale. | Number of participants answering the GBI questionnaire at 3 months | Posted | Mean | Standard Deviation | Score | 3 months after surgery |
|
|
|
| 0 |
| 51 |
| 1 |
| 51 |
| 16 |
| 51 |
|
|
| Infection | Infections and infestations | Non-systematic Assessment | Infection around abutment area. |
|
| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Bleeding around abutment. |
|
| Inflammation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Inflammation around abutment. |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| All study visits : Holgers 3 |
|
| All study visits : Holgers 4 |
|
| 9 days : Holgers 0 |
|
| 9 days : Holgers 1 |
|
| 9 days : Holgers 2 |
|
| 9 days : Holgers 3 |
|
| 9 days : Holgers 4 |
|
| 5 weeks : Holgers 0 |
|
| 5 weeks : Holgers 1 |
|
| 5 weeks : Holgers 2 |
|
| 5 weeks : Holgers 3 |
|
| 5 weeks : Holgers 4 |
|
| 3 months : Holgers 0 |
|
| 3 months : Holgers 1 |
|
| 3 months : Holgers 2 |
|
| 3 months : Holgers 3 |
|
| 3 months : Holgers 4 |
|
| 6 months : Holgers 0 |
|
| 6 months : Holgers 1 |
|
| 6 months : Holgers 2 |
|
| 6 months : Holgers 3 |
|
| 6 months : Holgers 4 |
|
| 12 months : Holgers 0 |
|
| 12 months : Holgers 1 |
|
| 12 months : Holgers 2 |
|
| 12 months : Holgers 3 |
|
| 12 months : Holgers 4 |
|
| Unplanned visits : Holgers 0 |
|
| Unplanned visits : Holgers 1 |
|
| Unplanned visits : Holgers 2 |
|
| Unplanned visits : Holgers 3 |
|
| Unplanned visits : Holgers 4 |
|
| Holgers 3 |
|
| Holgers 4 |
|
| Title | Measurements |
|---|---|
|
| All study visits : I-score 3 |
|
| All study visits : I-score 4 |
|
| All study visits : P-score 0 |
|
| All study visits : P-score 1 |
|
| All study visits : P-score 2 |
|
| All study visits : S-score 0 |
|
| All study visits : S-score 1 |
|
| All study visits : S-score 2 |
|
| 9 days : I-score 0 |
|
| 9 days : I-score 1 |
|
| 9 days : I-score 2 |
|
| 9 days : I-score 3 |
|
| 9 days : I-score 4 |
|
| 9 days : P-score 0 |
|
| 9 days : P-score 1 |
|
| 9 days : P-score 2 |
|
| 9 days : S-score 0 |
|
| 9 days : S-score 1 |
|
| 9 days : S-score 2 |
|
| 5 weeks : I-score 0 |
|
| 5 weeks : I-score 1 |
|
| 5 weeks : I-score 2 |
|
| 5 weeks : I-score 3 |
|
| 5 weeks : I-score 4 |
|
| 5 weeks : P-score 0 |
|
| 5 weeks : P-score 1 |
|
| 5 weeks : P-score 2 |
|
| 5 weeks : S-score 0 |
|
| 5 weeks : S-score 1 |
|
| 5 weeks : S-score 2 |
|
| 3 months : I-score 0 |
|
| 3 months : I-score 1 |
|
| 3 months : I-score 2 |
|
| 3 months : I-score 3 |
|
| 3 months : I-score 4 |
|
| 3 months : P-score 0 |
|
| 3 months : P-score 1 |
|
| 3 months : P-score 2 |
|
| 3 months : S-score 0 |
|
| 3 months : S-score 1 |
|
| 3 months : S-score 2 |
|
| 6 months : I-score 0 |
|
| 6 months : I-score 1 |
|
| 6 months : I-score 2 |
|
| 6 months : I-score 3 |
|
| 6 months : I-score 4 |
|
| 6 months : P-score 0 |
|
| 6 months : P-score 1 |
|
| 6 months : P-score 2 |
|
| 6 months : S-score 0 |
|
| 6 months : S-score 1 |
|
| 6 months : S-score 2 |
|
| 12 months : I-score 0 |
|
| 12 months : I-score 1 |
|
| 12 months : I-score 2 |
|
| 12 months : I-score 3 |
|
| 12 months : I-score 4 |
|
| 12 months : P-score 0 |
|
| 12 months : P-score 1 |
|
| 12 months : P-score 2 |
|
| 12 months : S-score 0 |
|
| 12 months : S-score 1 |
|
| 12 months : S-score 2 |
|
| Unplanned visits : I-score 0 |
|
| Unplanned visits : I-score 1 |
|
| Unplanned visits : I-score 2 |
|
| Unplanned visits : I-score 3 |
|
| Unplanned visits : I-score 4 |
|
| Unplanned visits : P-score 0 |
|
| Unplanned visits : P-score 1 |
|
| Unplanned visits : P-score 2 |
|
| Unplanned visits : S-score 0 |
|
| Unplanned visits : S-score 1 |
|
| Unplanned visits : S-score 2 |
|
| 5 weeks : No |
|
| 3 months : Yes |
|
| 3 months : No |
|
| Unplanned visits : Yes |
|
| Unplanned visits : No |
|
| Title | Measurements |
|---|---|
|
| 5 weeks : No |
|
| 3 months : Yes |
|
| 3 months : No |
|
| 6 months : Yes |
|
| 6 months : No |
|
| 12 months : Yes |
|
| 12 months : No |
|
| Unplanned visits : Yes |
|
| Unplanned visits : No |
|
| Title | Measurements |
|---|---|
|
| All study visits : Skin dehiscence around abutment |
|
| All study visits : Other |
|
| 9 days : None |
|
| 9 days : Bleeding and/or hematoma |
|
| 9 days : Hair in-growth |
|
| 9 days : Skin dehiscence around abutment |
|
| 9 days : Other |
|
| 5 weeks : None |
|
| 5 weeks : Bleeding and/or hematoma |
|
| 5 weeks : Hair in-growth |
|
| 5 weeks : Skin dehiscence around abutment |
|
| 5 weeks : Other |
|
| 3 months : None |
|
| 3 months : Bleeding and/or hematoma |
|
| 3 months : Hair in-growth |
|
| 3 months : Skin dehiscence around abutment |
|
| 3 months : Other |
|
| 6 months : None |
|
| 6 months : Bleeding and/or hematoma |
|
| 6 months : Hair in-growth |
|
| 6 months : Skin dehiscence around abutment |
|
| 6 months : Other |
|
| 12 months : None |
|
| 12 months : Bleeding and/or hematoma |
|
| 12 months : Hair in-growth |
|
| 12 months : Skin dehiscence around abutment |
|
| 12 months : Other |
|
| Unplanned visits : None |
|
| Unplanned visits : Bleeding and/or hematoma |
|
| Unplanned visits : Hair in-growth |
|
| Unplanned visits : Skin dehiscence around abutment |
|
| Unplanned visits : Other |
|
| Title | Measurements |
|---|---|
|
| 9 days : Yes |
|
| 5 weeks : No |
|
| 5 weeks : Yes |
|
| 3 months : No |
|
| 3 months : Yes |
|
| 6 months : No |
|
| 6 months : Yes |
|
| 12 months : No |
|
| 12 months : Yes |
|
| Unplanned visits : No |
|
| Unplanned visits : Yes |
|
| Title | Measurements |
|---|---|
|
| 9 days : Presence of numbness |
|
| 5 weeks : No numbness |
|
| 5 weeks : Presence of numbness |
|
| 3 months : No numbness |
|
| 3 months : Presence of numbness |
|
| 6 months : No numbness |
|
| 6 months : Presence of numbness |
|
| 12 months : No numbness |
|
| 12 months : Presence of numbness |
|
| Unplanned visits : No numbness |
|
| Unplanned visits : Presence of numbness |
|
| Title | Measurements |
|---|---|
|
| Physical support score |
|