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Trial record 2 of 106 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting. (HColl_HTO)

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ClinicalTrials.gov Identifier: NCT03601130
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
SurgaColl Technologies Limited

Brief Summary:
The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. HydroxyColl bone graft substitute will be evaluated when utilized in Open Wedge High Tibial Osteotomy with medial plate fixation. Its safety profile will be evaluated as defined by the number of reported adverse events.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: HydroxyColl Bone Graft Substitute Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Market Clinical Follow up - Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Bone Graft
Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting)
Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)
The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.

Active Comparator: HydroxyColl Bone Graft Substitute
Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute.
Device: HydroxyColl Bone Graft Substitute
The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) with the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.

Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)
The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.




Primary Outcome Measures :
  1. Radiological Healing [ Time Frame: Week 6 ]
    clinical assessment of healing based on radiological observations by a member of the clinical team

  2. Radiological Healing [ Time Frame: Week 12 ]
    clinical assessment of healing based on radiological observations by a member of the clinical team

  3. Radiological Healing [ Time Frame: Week 52 ]
    clinical assessment of healing based on radiological observations by a member of the clinical team

  4. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Day 0 ]
    Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  5. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Day 1 ]
    Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  6. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 6 ]
    Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  7. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 12 ]
    Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  8. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 52 ]
    Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  9. EQ5D Score [ Time Frame: Day 0 ]
    Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  10. EQ5D Score [ Time Frame: Day 1 ]
    Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  11. EQ5D Score [ Time Frame: Week 6 ]
    Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  12. EQ5D Score [ Time Frame: Week 12 ]
    Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  13. EQ5D Score [ Time Frame: Week 52 ]
    Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  14. VAS Score [ Time Frame: Day 0 ]
    Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].

  15. VAS Score [ Time Frame: Day 1 ]
    Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].

  16. VAS Score [ Time Frame: Week 6 ]
    Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].

  17. VAS Score [ Time Frame: Week 12 ]
    Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].

  18. VAS Score [ Time Frame: Week 52 ]
    Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].


Secondary Outcome Measures :
  1. Safety outcome based on clinical assessment of the adverse events reported during the trial. [ Time Frame: Day 0 ]
    Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.

  2. Safety outcome based on clinical assessment of the adverse events reported during the trial [ Time Frame: Day 1 ]
    Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.

  3. Safety outcome based on clinical assessment of the adverse events reported during the trial [ Time Frame: Week 6 ]
    Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.

  4. Safety outcome based on clinical assessment of the adverse events reported during the trial [ Time Frame: Week 12 ]
    Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.

  5. Safety outcome based on clinical assessment of the adverse events reported during the trial [ Time Frame: Week 52 ]
    Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to give written informed consent to participate in this study
  • Both male and females who will be admitted to the hospital for treatment of varus mis-alignment in medial unicompartmental osteoarthritis of the knee of the degree to which the surgeon deems it necessary to include a bone grafting procedure
  • Kellgren-Lawrence grade 1-4
  • Ability and willingness to comply with all study requirements

Exclusion Criteria:

  • History or presence of the following conditions: known sensitivity to bovine collagen or hydroxyapatite materials; diabetes, immune-compromised, vascular disease, metabolic/systemic bone disorder, osteomyelitis
  • Failure to provide written informed consent
  • Severe acute or chronic medical illness, including symptomatic cardiovascular disease
  • Weight less than 40 kilograms
  • Any clinically significant abnormality at the time of submission, in the judgement of the investigator would preclude safe completion of the study
  • Any use of estrogens, estrogen-progestin therapy, selective estrogens receptor modulators (SERMs) or calcitonin within 3 months, and use of bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues within the last 6 months
  • History of alcohol or drug abuse within the last year
  • History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
  • Significant psychiatric disorder or behaviour
  • Presence of any concomitant condition which, in the opinion of the investigator or the sponsor, may interfere with the interpretation of efficacy and safety data gathered in this study including chronic infections
  • Chronic or >7 days concomitant use of oral corticosteroids within 1 month prior to screening
  • Regular smoker (more than 10 cigarettes per day) for the last 12 months
  • Participation in another interventional orthopaedic clinical trial within 1 month of the beginning of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601130


Contacts
Contact: Angie Dempster +44 (0)1256 315073 Angie.Dempster@hhft.nhs.uk
Contact: John P Gleeson, PhD +353 (0)1 700 ext 7878 john.gleeson@surgacoll.com

Locations
United Kingdom
Basingstoke & North Hampshire Hospital Recruiting
Basingstoke, United Kingdom
Contact: Angie Dempster    00447867141077    Angie.Dempster@hhft.nhs.uk   
Contact: Paula Chatterton    00441256 313204    Paula.Chatterton@hhft.nhs.uk   
Principal Investigator: Michael Risebury, MA MBBS FRCS         
Sponsors and Collaborators
SurgaColl Technologies Limited
Investigators
Principal Investigator: Michael Risebury, MA MBBS FRCS Hampshire Hospitals NHS Foundation Trust

Responsible Party: SurgaColl Technologies Limited
ClinicalTrials.gov Identifier: NCT03601130     History of Changes
Other Study ID Numbers: SC100.2
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SurgaColl Technologies Limited:
osteotomy
osteoarthritis
bone graft substitute

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases